COMMISSION STAFF WORKING DOCUMENT Accompanying the documents Proposal for a Regulation of the European Parliament and of the Council amending Regulations (EC) No 178/2002, (EC) No 401/2009, (EU) 2017/745 and (EU) 2019/1021 of the European Parliament and of the Council as regards the re-attribution of scientific and technical tasks and improving cooperation among Union agencies in the area of chemicals and Proposal for a Directive of the European Parliament and the Council amending Directive 2011/65/EU of the European Parliament and of the Council as regards the re-attribution of scientific and technical tasks to the European Chemicals Agency
Date: 2023-12-07
Institutions: Directorate-General for Environment, European Commission
Subjects: European Agency for Safety and Health at Work, European Chemicals Agency, European Environment Agency, European Food Safety Authority, European Medicines Agency, chemical product, chemicals legislation, dangerous substance, exchange of information, operation of the Institutions, scientific report

EN 

  EN 

   EUROPEAN COMMISSION  Brussels, 7.12.2023  SWD(2023) 850 final  COMMISSION STAFF WORKING DOCUMENT   Accompanying the documents   Proposal for a Regulation of the European Parliament and of the Council amending Regulations (EC) No 178/2002,  (EC) No 401/2009,  (EU) 2017/745 and  (EU) 2019/1021 of the European Parliament and of the Council as regards the re-attribution of scientific and technical tasks and improving cooperation among Union agencies in the area of chemicals     and    Proposal for a Directive of the European Parliament and the Council amending Directive 2011/65/EU of the European Parliament and of the Council as regards the re-attribution of scientific and technical tasks to the European Chemicals Agency     {COM(2023) 783 final} - {COM(2023) 781 final}  
 
 
Table of contents 

1. 

INTRODUCTION: POLITICAL AND LEGAL CONTEX    ………….…………………………………...……..3 

1.1  Political context .............................................................................................................. 3 

1.2  Legal context ................................................................................................................. 4 

1.3  Scope of the document ...................................................................................................... 6 

PROBLEM DEFINITION .................................................................................................................................................. 7 

OBJECTIVES: WHAT IS TO BE ACHIEVED? ............................................................................................................. 8 

AVAILABLE OPTIONS .................................................................................................................................................... 8 

STAKEHOLDER VIEWS ................................................................................................................................................ 10 

SCIENTIFIC  AND  TECHNICAL  WORK  ON  CHEMICALS  FOR  (RE-)ATTRIBUTION  TO  THE  EU 
AGENCIES AND STRENGTHENING THE COOPERATION AMONG THE AGENCIES ................................. 11 

ASSESSMENT OF IMPACTS ........................................................................................................................................ 19 

IMPACTS OF THE LEGISLATIVE PROPOSALS ON REATTRIBUTION OF TASKS ....................................... 20 

IMPACT OF THE LEGISLATIVE PROPOSAL FOR A REGULATION ESTABLISHING A COMMON DATA 
PLATFORM AND A MONITORING AND OUTLOOK FRAMEWORK FOR CHEMICALS ........................ …23 

2. 

3. 

4. 

5. 

6. 

7. 

8. 

9. 

10.  OVERALL IMPACTS FROM ALL (RE-)ATTRIBUTIONS ...................................................................................... 29 

10.1 Added value and synergies of the (re-)attributions .................................................................... 29 

10.2 Overall impact on resources ............................................................................................. 30 

10.3 Overall impacts on ECHA ................................................................................................ 34 

10.4 Overall impacts on EEA .................................................................................................. 36 

10.5 Overall impacts on EFSA ................................................................................................. 37 

10.6 Overall impacts on EMA ................................................................................................. 39 

10.7 Overall impacts on EU-OSHA ........................................................................................... 41 

ANNEX I: MISSION, CORE ACTIVITIES, COMPETENCES AND SCIENTIFIC BODIES OF THE AGENCIES .... 42 

1. 

2. 

3. 

4. 

5. 

EUROPEAN FOOD SAFETY AUTHORITY .......................................................................................................... ….42 

EUROPEAN CHEMICALS AGENCY .......................................................................................................................... 44 

EUROPEAN MEDICINES AGENCY............................................................................................................................ 46 

EUROPEAN ENVIRONMENT AGENCY ................................................................................................................... 48 

EUROPEAN AGENCY FOR SAFETY AND HEALTH AT WORK ........................................................................ 50 

ANNEX II: SUMMARY OF THE FEEDBACK RECEIVED THROUGH THE PUBLIC CONSULTATION ON THE 
CALL FOR EVIDENCE FOR THE INITIATIVE ON (RE-)ATTRIBUTION OF SCIENTIFIC AND TECHNICAL 
WORK ON CHEMICALS TO THE EU AGENCIES ................................................................................................... 52 

1. 

2. 

3. 

4. 

5. 

RESPONDENTS ............................................................................................................................................................... 52 

TYPE OF RESPONSES ................................................................................................................................................... 52 

SUPPORT TO THE INITIATIVE ON 1S1A ................................................................................................................. 52 

SCOPE AND OBJECTIVES OF 1S1A ........................................................................................................................... 54 

REATTRIBUTION OF TASKS TO EU AGENCIES ................................................................................................... 57 

ANNEX III: DETAILED IMPACT ANALYSIS OF THE (RE-)ATTRIBUTION OF SCIENTIFIC AND TECHNICAL 
WORK RELATED TO CHEMICALS TO EU AGENCIES ........................................................................................ 60 

1. 

2. 

3. 

DRINKING WATER DIRECTIVE (2020/2184) ........................................................................................................... 60 

REGULATION ON SERIOUS CROSS-BORDER THREATS TO HEALTH (2022/2371) .................................... 64 

EUROPEAN PARTNERSHIP FOR THE ASSESSMENT OF RISKS FROM CHEMICALS (PARC) ................. 66 

1 

 
 
4. 

5. 

6. 

7. 

8. 

COMMISSION IMPLEMENTING DECISION 2022/1979 UNDER SEVESO DIRECTIVE ................................. 69 

BATTERIES REGULATION (PROPOSAL) ................................................................................................................ 76 

E-PRTR REGULATION (2006/166) .............................................................................................................................. 81 

INDUSTRIAL EMISSIONS DIRECTIVE (2010/75/EU) ............................................................................................. 82 

ENVIRONMENTAL  QUALITY  STANDARD  DIRECTIVE  (2008/105/EC)  +  WATER  FRAMEWORK 
DIRECTIVE (2000/60/EC) + GROUNDWATER DIRECTIVE (2006/118/EC) ....................................................... 85 

9. 

CLP REGULATION (1272/2008) ................................................................................................................................... 96 

10.  PACKAGING AND PACKAGING WASTE DIRECTIVE ....................................................................................... 100 

11.  LEGISLATION ON MEDICINAL PRODUCTS FOR HUMAN USE (726/2004) ................................................. 101 

12.  END-OF LIFE VEHICLES (ELV) DIRECTIVE ......................................................................................................... 105 

13.  TOY SAFETY DIRECTIVE .......................................................................................................................................... 110 

14.  RESTRICTION OF HAZARDOUS SUBSTANCE (ROHS) DIRECTIVE (2011/65/EU) ..................................... 115 

15.  POPS REGULATION (2019/1021) ............................................................................................................................... 121 

16.  MEDICAL DEVICES REGULATION ........................................................................................................................ 129 

17.  EEA FOUNDING REGULATION (1210/90) .............................................................................................................. 134 

18.  GENERAL FOOD LAW (178/2002) ............................................................................................................................ 137 

19.  EU COMMON DATA PLATFORM ON CHEMICALS ........................................................................................... 139 

20. 

21. 

INFORMATION PLATFORM FOR CHEMICAL MONITORING (IPCHEM) ..................................................... 148 

INFORMATION ON REGULATORY PROCESSES ON CHEMICALS ............................................................... 155 

22.  REPOSITORY OF REFERENCE VALUES ............................................................................................................... 163 

23. 

INFORMATION ON THE OBLIGATIONS UNDER UNION ACTS ON CHEMICALS .................................... 168 

24.  DATABASE ON ENVIRONMENTAL SUSTAINABILITY RELATED INFORMATION ................................ 171 

25.  MECHANISM FOR INITIATING TESTING AND MONITORING ...................................................................... 173 

26.  MECHANISM FOR NOTIFICATION OF STUDIES ................................................................................................ 176 

27.  EU  CHEMICAL  EARLY  WARNING  AND  ACTION  SYSTEM  AND  INDICATOR  FRAMEWORK  FOR 
CHEMICALS................................................................................................................................................................... 179 

28.  OBSERVATORY  FOR  SPECIFIC  CHEMICALS  WITH  POTENTIAL  CONTRIBUTION  TO  EMERGING 
CHEMICAL RISKS ........................................................................................................................................................ 184 

29.  COOPERATION OF ECHA WITH OTHER EU AGENCIES .................................................................................. 187 

30.  SCIENTIFIC OPINIONS ON OCCUPATIONAL EXPOSURE LIMITS ................................................................ 190 

31.  REACH REGULATION (1907/2006)........................................................................................................................... 192 

32.  COSMETIC PRODUCTS REGULATION .................................................................................................................. 196 

33.  SCIENTIFIC COMMITTEES AND THEIR SECRETARIAT (SCCS/SCHEER) ................................................... 204 

34.  ECODESIGN FOR SUSTAINABLE PRODUCTS REGULATION ........................................................................ 212 

35.  TOBACCO PRODUCTS DIRECTIVE ........................................................................................................................ 213 

36.  REGULATION ON FLUORINATED GREENHOUSE GASES AND REGULATION ON OZONE DEPLETING 
SUBSTANCES ................................................................................................................................................................ 214 

2 

 
 
 
 
 
 
1. 

INTRODUCTION: POLITICAL AND LEGAL CONTEXT 

1.1 

Political context  

Chemicals are everywhere in our daily lives and play a fundamental role in most of our activities, as they form 
part  of  virtually  every  device  we  use  to ensure  our  well-being (be it for  food,  electronics, toys,  clothes  or 
industrial machines), protect our health and security, and meet new challenges through innovation. The EU is 
the second largest producer of chemicals in the world with EUR 541 billion turnover in 2018 (7.0% of EU 
manufacturing by turnover) and 14.4% of global sales in 2020 (CEFIC, 2022)1 and chemical manufacturing is 
the  fourth  largest  industry  in  the  EU  comprising  30  000  companies,  95%  of  which  are  SMEs,  directly 
employing approximately 1.2 million people and 3.6 million indirectly.   

At the same time, chemicals can cause harm to human health and the environment. Certain chemicals cause 
cancers,  affect  the  immune,  respiratory,  endocrine,  reproductive  and  cardiovascular  systems  and  increase 
vulnerability to diseases. Exposure to these harmful chemicals is therefore a threat to human health. In addition, 
the pollution of environment with chemicals is one of the key drivers putting the Earth at risk2, impacting and 
amplifying  planetary  crises  such  as  climate  change,  degradation  of  ecosystems  and  loss  of  biodiversity, 
examples being negative effects on pollinators, insects, aquatic ecosystems and bird population.  

In order to ensure a high level of protection of human health and the environment from the adverse effects of 
chemicals and to support the efficient functioning of the internal market for chemicals while promoting the 
competitiveness  and  innovation  of  EU  industry,  the  European  Union  has  developed  a  comprehensive 
regulatory framework for chemicals.  

The framework has been developed progressively, with the first legislation coming in place as early as in 1967. 
The framework consists currently of over 40 pieces of legislation, addressing: the production and placing on 
the market of chemicals and chemical products, such as (e.g. industrial chemicals, biocidal products, plant 
protection  products,  human  and  veterinary  pharmaceuticals,  cosmetic  products,  detergents),  emissions  of 
chemicals (e.g. from industrial installations,  waste water treatment plants or use of fertilisers), protection of 
workers’ health (e.g. from carcinogens, mutagens and reprotoxic substances, from asbestos, or from chemical 
agents in general), chemicals in waste (e.g. in general, in packaging and packaging waste or in end-of-life 
vehicles), safety of consumer products (e.g. toys, food contact materials, batteries), safety of foodstuff and 
feedstuff (e.g. food improvements agents or maximum residue levels of food contaminants ) and protection 
of the environmental compartments (e.g. surface waters, ground waters, marine waters, drinking water, air 
and soil).  

The fitness check of the most relevant chemicals legislation assessing over 40 pieces of legislation concluded 
that overall the EU chemicals legislation delivers results as intended and is fit-for-purpose, but a number of 
significant weaknesses prevent the EU chemicals legislation from living up to its full potential. There were 
identified shortcomings across legislative pieces as regards the coherence of safety assessments, efficiency of 
the underlying technical and scientific work and the coherence of transparency rules. These shortcomings can 
lead to inconsistency and incoherence in safety assessments, slow procedures, inefficient use of resources, 
unnecessary  burden,  (perceived)  lack  of  transparency  and  sometimes  low  quality  of  scientific  advice  (see 
section 2). 

Building on the findings of the fitness check, the European Green Deal announced the commitment ‘to review 
how to use better the EU’s agencies and scientific bodies to move towards a process of ‘one substance, one 
assessment’  and  to  provide  greater  transparency  when  prioritising  action  to  deal  with  chemicals’.  The 
Chemicals Strategy for Sustainability elaborated further on the concept of ‘one substance, one assessment’ and 
defined it  as  an  approach to  improve the  overall  efficiency,  coherence  and  transparency  of the  delivery  of 
safety  assessments  of  chemicals  across  legislation.  The  strategy  identified  five  key  areas  affecting  the 
coherence and efficiency of delivery of safety assessments and for each of them defined number of specific 

1 Within the EU, two thirds of these sales are generated in four Member States: Germany (32.1%), France (13.5%), Italy (10.7%) and 
the Netherlands (8.9%) (CEFIC, 2022). See Annex 18 for more information on the chemical sector in the EU. 
2 Rockström, J. et al., Planetary Boundaries: Exploring the Safe Operating Space for Humanity. Ecology and Society, 
2009 

3 

 
 
 
objectives and actions (see sections 2 and 3). Two key actions identified are to ‘rationalise the use of expertise 
and resources by proposing the reattribution of technical and scientific work on chemicals performed 
under the relevant pieces of legislation to European agencies, including work of the Scientific Committee 
on  Health,  Environmental  and  Emerging  Risks  (SCHEER)  and  Scientific  Committee  on  Consumer  Safety 
(SCCS)’  and to  ensure  ‘a clear allocation  of responsibilities  and  good  cooperation  among  the  European 
Agencies’. 

The EU Action Plan ‘Towards Zero Pollution for Air, Water and Soil’ further contributed to the one substance, 
one assessment objectives through commitments to consolidate the roles of the European Environment Agency 
and the Commission’s Joint Research Centre in close collaboration with the European Chemicals Agency, the 
European Food Safety Agency, the European Maritime Safety Agency and other relevant agencies as the EU’s 
Knowledge Centres of Excellence for Zero Pollution Monitoring and Outlook Framework. 

The European Parliament resolution of 10 July 2020 welcomed the Strategy and the ‘one substance – one hazard 
assessment’ principle in order to better use the resources of the Union’s agencies and scientific bodies, avoid 
duplication of efforts, reduce the risk of diverging outcomes of assessments, speed up and bring consistency 
and transparency to chemicals regulation, and ensure enhanced health and environmental protection and a level 
playing field for industry. The resolution called to achieve coherence and synergies between legislation dealing 
with chemicals and chemical products, specific products regulation, general product legislation, legislation on 
environmental  compartments,  legislation  on  sources  of  pollution  and  legislation  on  waste.  The  resolution 
further  called  to  pay  special  attention  to  reducing  overlaps  between  legal  frameworks,  and  between  tasks 
allocated to the European Chemicals Agency, the European Food Safety Agency and the European Medicines 
Agency.  The  resolution  also  underlined  the  need  to  reinforce  cooperation  and  coordination  between  the 
European  evaluation  agencies  EFSA  and  ECHA  together  with  national  agencies,  by  developing  common 
guidelines for risk assessment, namely for biocidal and phytopharmaceutical products, which take into account 
the most recent scientific results, so as to avoid inconsistencies. Finally, the European Parliament called on the 
Commission and Council to refrain from cutting ECHA’s resources in annual budget procedures and to provide 
ECHA with additional resources for any other tasks that may be required, such as conducting evaluations of 
substances. 

The Council conclusions of 15 March 2021 also welcomed the Strategy and the ‘one substance, one assessment’ 
approach intending to simplify and improve the transparency of the regulatory framework for hazard and risk 
assessment of chemicals, to enhance coherence, to better coordinate the EU rules on chemicals, and to make 
decision-making faster. The conclusions called to continue ensuring policy coherence and exploit synergies 
among  the  chemicals  and  other  policies.  The  conclusion  further  emphasised  that  the  one  substance,  one 
assessment approach should not create delays in regulatory actions nor increase administrative burden, that the 
Member States are closely involved in the development of the approach and that the right of initiative of the 
Member States to initiate regulatory action is maintained. The conclusions also underlined the importance of 
allocating  the necessary  resources  for the  European  agencies  in  the light of the envisaged  re-attribution  of 
technical and scientific work on chemicals, including an appropriate and long-term budgetary framework, and, 
in  particular,  for  ECHA,  taking  into  consideration  their  central  role  in  the  implementation  of  some  key 
objectives of the Chemicals Strategy.  

1.2 

Legal context  

The reattribution of existing tasks or attribution of new tasks to EU Agencies requires targeted amendments of 
the existing pieces of legislation on chemicals. The  preferred way of doing it is by introducing changes in 
allocation of tasks when the individual pieces of legislation are being revised. Therefore, the relevant changes 
have been already proposed as part of the proposals for the regulation on serious cross-border threats to health3 

3 Regulation (EU) 2022/2371 of the European Parliament and of the Council of 23 November 2022 on serious cross-
border threats to health and repealing Decision No 1082/2013/EU (OJ L 314 6.12.2022, p. 26). 

4 

 
 
 
and for revisions of drinking water directive4, SEVESO III directive5, batteries regulation6, EPRTR regulation7, 
industrial  emissions  directive8,  water  framework  directive,  ground  water  directive,  environmental  quality 
standard  directive9,  CLP  regulation10,  packaging  and  packaging  waste  directive11,  legislation  on  medicinal 
products for human use12,13, end-of-life vehicles directive14 and directive on the safety of toys15. The relevant 
changes, including new or additional tasks, are also planned to be introduced in the upcoming proposals for a 
regulation on ECHA16 and for the revisions of REACH17 and cosmetics regulation18.  

Where  the  chemical legislation  is  not  to  be  opened within  this mandate  of  the  Commission,  the  necessary 
changes in allocation of tasks  is introduced through the horizontal proposals on reattribution of tasks to the 
EU Agencies consisting of a regulation and a directive, for reasons of legal consistency. The proposal for the 
regulation proposes  targeted  amendments to  allocations  of tasks in the  POPs regulation19,  medical  devices 

4 Directive (EU) 2020/2184 of the European Parliament and of the Council of 16 December 2020 on the quality of 
water intended for human consumption (OJ L 435 23.12.2020, p. 1). 
5 Commission Implementing Decision (EU) 2022/1979 of 31 August 2022 on establishing the form and databases for 
communicating the information referred to in Articles 18(1) and 21(3) of Directive 2012/18/EU of the European 
Parliament and of the Council on the control of major-accident hazards involving dangerous substances and repealing 
Commission Implementing Decision 2014/895/EU (OJ L 272 20.10.2022, p. 14). 
6 Regulation (EU) 2023/1542 of the European Parliament and of the Council of 12 July 2023 concerning batteries and 
waste batteries, amending Directive 2008/98/EC and Regulation (EU) 2019/1020 and repealing Directive 2006/66/EC 
(OJ L 191, 28.7.2023, p.1). 
7 Proposal for a Regulation of the European Parliament and of the Council on reporting of environmental data from 
industrial installations and establishing an Industrial Emissions Portal (COM/2022/157 final). 
8 Proposal for a Directive of the European Parliament and of the Council amending Directive 2010/75/EU of the 
European Parliament and of the Council of 24 November 2010 on industrial emissions (integrated pollution prevention 
and control) and Council Directive 1999/31/EC of 26 April 1999 on the landfill of waste (COM (2022) 156 final). 
9 Proposal for a Directive of the European Parliament and of the Council amending Directive 2000/60/EC establishing a 
framework for Community action in the field of water policy, Directive 2006/118/EC on the protection of groundwater 
against pollution and deterioration and Directive 2008/105/EC on environmental quality standards in the field of water 
policy (COM(2022) 540 final). 
10 Proposal for a Regulation of the European Parliament and of the Council amending Regulation (EC) No 1272/2008 of 
the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures 
(COM (2022) 748 final). 
11 Proposal for a regulation of the European Parliament and of the Council on packaging and packaging waste, 
amending Regulation (EU) 2019/1020 and Directive (EU) 2019/904, and repealing Directive 94/62/EC (COM(2022) 
677 final). 
12 Proposal for a Directive of the European Parliament and of the Council on the Union code relating to medicinal 
products for human use, and repealing Directive 2001/83/EC and Directive 2009/35/EC (COM (2023) 192 final). 
13 Proposal for a Regulation of the European Parliament and of the Council laying down Union procedures for the 
authorisation and supervision of medicinal products for human use and establishing rules governing the European 
Medicines Agency, amending Regulation (EC) No 1394/2007 and Regulation (EU) No 536/2014 and repealing 
Regulation (EC) No 726/2004, Regulation (EC) No 141/2000 and Regulation (EC) No 1901/2006 (COM (2023) 193 
final).  
14 Proposal for a Regulation of the European Parliament and of the Council on circularity requirements for vehicle 
design and on management of end-of-life vehicles, amending Regulation (EU) 2018/858 and 2019/1020 and repealing 
Directives 2000/53/EC and 2005/64/EC (COM (2023) 451 final).  
15 Proposal for a Regulation of the European Parliament and of the Council on the safety of toys and repealing Directive 
2009/48/EC (COM(2023) 462 final). 
16 European Chemicals Agency – proposal for a basic regulation (europa.eu) 
17 Chemicals legislation – revision of REACH Regulation to help achieve a toxic-free environment (europa.eu) 
18 EU chemicals strategy for sustainability – Cosmetic Products Regulation (revision) (europa.eu) 
19 Regulation (EU) 2019/1021 of the European Parliament and of the Council of 20 June 2019 on persistent organic 
pollutants (OJ L 169 25.6.2019, p. 45) 

5 

 
 
 
regulation20, EEA founding regulation21 and the general food law22, while the proposal for a directive proposes 
targeted amendments to allocations of tasks in the RoHS directive23.  

The  Proposal  for  a Regulation of  the European  Parliament and  of  the Council establishing  a  common  data 
platform  on  chemicals,  laying  down  rules  to  ensure  that  the  data  contained  in  it  are  findable,  accessible, 
interoperable and reusable and establishing a monitoring and outlook framework for chemicals is a standalone 
regulation  aiming  to  implement  one  substance,  one  assessment  actions  related  to  data,  information  and 
transparency, namely: 

•  use a single ‘Public activities coordination tool’ to provide an up-to-date overview of all planned and 

ongoing initiatives on chemicals by authorities across legislation; 

•  develop  a  common  open  data  platform  on  chemicals to  facilitate  the  sharing,  access  and  re-use  of 

information on chemicals coming from all sources; 

•  promote reuse and harmonisation of human and environmental health-based limit values among EU 

• 

• 

• 

• 

risk assessors and managers through a centralised and curated EU repository; 
remove legislative obstacles  for  the  re-use  of data  and  better  streamline  the  flow  of  chemical  data 
between EU and national authorities; 
establish tools and practices to ensure that relevant academic data is easily and readily accessible for 
safety assessments and is suitable for regulatory purposes; 
enable EU  authorities to commission testing and monitoring of substances as part of the regulatory 
framework when further information is considered necessary; 
extend the principle of open data and the relevant transparency principles from the EU food safety 
sector to other pieces of chemical legislation; 

•  develop  an  EU  early  warning  and  action  system  for  chemicals  to  ensure  that  EU  policies  address 

emerging chemical risks as soon as identified by monitoring and research.  

In order to implement these actions, the proposal also allocates some new tasks to EU agencies as regards the 
management,  sharing  and  generation  of  data  and  information,  operation  of  a  monitoring  and  outlook 
framework for chemicals and formalises some existing tasks.  

1.3 

Scope of the document 

This  document  summarises  all  actions  taken  as  of  2020  to  (re-)attribute  scientific  and  technical  work  on 
chemicals to EU agencies and to ensure good cooperation among the EU agencies in the area of chemicals. 
The document accompanies the horizontal legislative proposals on reattribution of tasks to EU agencies, and 
explains  changes  in  (re-)attributions  proposed  in  those  proposals.  It  also  explains,  for  the  purpose  of 
completeness of  information changes which will be made to allocation of tasks via revisions of individual 
pieces of legislation or via a new legislation, including via the proposal for a Regulation on establishing a 
common data platform on chemicals, laying down rules to ensure that the data contained in it are findable, 
accessible,  interoperable and  reusable and  establishing  a  monitoring and  outlook  framework for  chemicals 
(‘proposal for a regulation establishing a common data platform and a monitoring and outlook framework for 
chemicals’).  The  document  explains  how  the  changes  in  allocation  of  tasks  to  EU  agencies  contribute  to 
achieving the one substance, one assessment objectives and provides an assessment of cumulative impacts of 
the changes in allocations of tasks on the functioning of the EU Agencies.  

20 Regulation (EU) of the European Parliament and of the Council of 5 April 2017 on medical devices, amending 
Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council 
Directives 90/385/EEC and 93/42/EEC (OJ L 117 5.5.2017, p.1) 
21 Regulation (EC) No 401/2009 of the European Parliament and of the Council of 23 April 2009 on the European 
Environment Agency and the European Information and Observation Network (OJ L 126 21.5.2009, p.13) 
22 Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the 
general principles and requirements of food law, establishing the European Food Safety Authority and laying down 
procedures in matters of food safety (OJ L 031 1.2.2002, p.1) 
23 Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of 
certain hazardous substances in electrical and electronic equipment (OJ L 174 1.7.2011, p.88) 

6 

 
 
 
2.  PROBLEM DEFINITION  

The EU regulatory framework for hazard and risk assessment and management of chemicals is comprehensive. 
It consists of many pieces of legislation, addressing production and placing on the market of chemicals and 
chemical products, emissions of chemicals, chemicals in waste, protection of workers’ health and safety of 
consumer products, foodstuff and feedstuff, and the environment. A high volume of technical and scientific 
work supports the implementation of the individual legislative acts. Depending on the legislation, the work is 
performed  using  different  data  and  methodologies  and  involving  various  EU  Agencies  (the  European 
Chemicals Agency (ECHA), the European Food Safety Authority (EFSA), the European Environment Agency 
(EEA), the European Medicine Agency (EMA) and the European Agency for Safety and Health at Work (EU-
OSHA)),  scientific committees,  (ad hoc)  expert groups,  Commission  services  or  external  contractors.  This 
situation may lead to inconsistent and incoherent outcomes of assessments across legislation (in respect of the 
same  chemicals),  inefficient  use  of  resources  and  unnecessary  costs  (from  operating  several  committees 
performing  similar  assessments,  from  assessing  the  same  chemical  by  several  committees/bodies  or  from 
duplicating supporting technical and scientific work). In addition, the assessments that are not performed by 
the EU Agencies are often being criticised by the stakeholders as not sufficiently transparent and inclusive, 
having insufficient scientific quality and robustness or having insufficient separation between risk assessment 
and risk management.  

The  key  drivers    that  one  substance,  one 
assessment approach intends to address are: 
•  Assessments  are  initiated  under  various 
pieces  of  legislation,  by  various  actors 
and at different points in time; 

•  Assessments  are  performed  by  various 
agencies,  scientific  committees,  expert 
groups or external consultants; 

•  Assessments  are  using  various  data  and 
availability, 
in 
they 
accessibility,  quality  and  are  stored  in 
different formats; 

varies 

their 

•  Assessments 

various 
methodologies and guidance documents; 
•  Various transparency rules and practices 

using 

are 

are applied. 

The key problems arising from these drivers that the legislative proposals on (re-)attribution of tasks to EU 
Agencies aim to address are: 

•  multiple actors performing scientific and technical work; 
•  varying degree of scientific robustness and procedural rigour of the actors performing scientific and 

• 
• 

technical work;  
incoherent methodologies and guidance documents; 
insufficient cooperation and coordination among the actors performing scientific and technical work 
on chemicals. 

The  other  problems  arising  from  these  drivers  are  being  addressed  as  part  of  other  ‘one  substance,  one 
assessment’ legislative as well as non-legislative actions. For example, the problems related to complicated 
accessibility  and  availability  of  data underlying the assessments  are  being addressed  by  the  proposal for a 
Regulation on establishing a common data platform on chemicals, laying down rules to ensure that the data 
contained in it are findable, accessible, interoperable and reusable and establishing a monitoring and outlook 
framework for chemicals. 

The problems have evolved as a consequence of the progressive development of the EU legislative framework 
for chemicals over the last 55 years and without this intervention, it will continue to persist.  

7 

 
 
 
 
3.  OBJECTIVES: WHAT IS TO BE ACHIEVED?  

The general objective of one substance, one assessment approach and of this initiative is to ensure coherent, 
efficient and transparent delivery of safety assessments of chemicals across EU chemical legislation  and thus 
contribute to a well-functioning single market for chemicals and a high level of protection of human health 
and the environment from chemicals. 

extent 

possible 

The specific objectives of the one substance, one 
assessment approach are: 
•  Initiation or triggering of the assessments is to 
the 
and 
coordinated  and  substances  are  assessed  in 
groups rather than substance-by-substance 
•  Responsibilities for performing the assessment 
are clear and allocated to make the best use of 
available expertise and resources and there is a 
good cooperation among all players 

synchronised 

•  Assessments  have  access to  all  available  data 
without technical and administrative burden 
•  Methodologies  used  are  coherent  and  to  the 

extent possible harmonised 

•  There  is  a  high  level  of  transparency  in 
performing  assessments  as  well  as  in  the 
underlying scientific data and information 

The specific objectives of the legislative proposals on (re-)attribution of tasks to EU Agencies are one step to 
achieve the one substance, one assessment approach. They are to ensure that: 

• 

• 

• 

allocation of responsibilities for performing the assessments and the underlying technical and scientific 
work  on chemicals is clear,  exploits and maximises synergies  and  makes  the  best  use  of  available 
expertise and resources; 
there is a good cooperation among all players on all aspects underling the assessment of chemicals 
(such as methodology development and exchange of data); 
the deliverables are of high scientific quality and the procedures are transparent and inclusive.  

4.  AVAILABLE OPTIONS 

Considering the problem drivers and the specific objectives to be achieved, there is very little discretion on the 
main policy choices. The preferred option is clearly to consolidate the technical and scientific work on 
chemicals performed under the relevant pieces of EU legislation in the EU Agencies and to strengthen 
the  cooperation  among the  EU  Agencies  as  regards  technical  and  scientific work  on chemicals.  The  EU 
agencies  have  been  founded  as  independent  bodies  with  adequate  funding,  they  maintain  the  necessary 
expertise, provide robust and high quality scientific work and follow transparent and inclusive procedures. 
Any other possible option (e.g. consolidation of work at other actors than EU Agencies or bringing all the 
existing actors at the same level of scientific robustness and procedural transparency and ensuring cooperation 
among them) would be less efficient, more expensive and provide less benefits.  

While the main policy option is clear and straightforward, there are sub-options as regards which tasks are 
suitable and useful to be reattributed to EU Agencies, which EU agency the (re-)attributed tasks should be 
assigned to and how and in which areas to strengthen the cooperation among the EU Agencies.  

Guiding principles for (re-)attribution of scientific and technical work to EU Agencies 

The  following  guiding  principles  were  developed  and  followed  to  identify  tasks  for  (re-)attribution  to  EU 
Agencies and to decide as to which EU Agency the task should be assigned:  

1.  The ‘technical and scientific work on chemicals’ is considered in a broad sense and includes: 

8 

 
 
 
 
 
 
 
 
 
assessments of risk from, hazard of and exposure to chemicals;  

• 
•  monitoring of occurrence and emissions of chemicals;  
•  determination of safe levels of chemicals for ecosystems and for humans;  
•  development of guidance documents;  
•  managing scientific committees, expert groups and network of experts;  
• 
•  hosting and operating (public) information platforms on chemicals;  
•  managing the data flows on chemicals and defining data formats; and 
•  assessments  of  socio-economic  consequences/impacts  of  risk  management  measures  on 

collecting, analysing and hosting data and information on chemicals and associated processes;  

chemicals.  

2.  The existing technical and scientific work on chemicals performed at EU level under, or in support of, 

all relevant EU legislation is considered. No legislation is a priory excluded.  

3.  Consider attributing the scientific and technical work related to safety assessment of chemicals to one 
of  the  EU  Agencies  with  a  mandate  related  to  chemicals,  i.e.  the  European  Chemicals  Agency 
(ECHA), the European Food Safety Authority (EFSA), the European Medicine Agency (EMA), the 
European Environment Agency (EEA) or the European Agency for Safety and Health at Work (EU-
OSHA);  

4.  Ensure fit with the core focus of the EU Agencies’ work on chemicals, in terms of use of substance 
in specific products, the route of exposure assessed, the type of sectors covered and mission of the 
agency. 

5.  Maximize synergies and coherence with ongoing activities, by attributing new activities on the basis 

of similarity with: 

•  Substances, data and data flows currently managed by the Agency;  
•  Existing expertise and competence; 
•  Output being provided by the Agency;  
•  Existing processes and procedures implemented by the Agency; 
•  Methodologies developed and applied by the Agency;  
•  Existing IT tools and planned developments; 
•  Networks of experts or committees governed or managed by the Agency. 

6.  Strive  that the (re-)attribution of tasks brings synergies and benefits to the Union beyond a mere shift 

of responsibilities. 

Solutions to strengthen the cooperation among the EU Agencies  

The following solutions were identified for strengthening the cooperation among the EU Agencies:  

1.  All agencies have equal legal obligations to cooperate with other agencies. The areas to be covered are 
those identified under the one substance, one assessment as affecting the coherence and efficiency of the 
assessments of chemicals, such as  
- 
- 
- 

development of methodologies,  
development of formats and controlled vocabularies,  
exchange of data and information related to chemicals and their assessment. 

9 

 
 
 
 
2.  All agencies have a clear and equal mandate to develop methodologies for assessments related to chemicals 
in  the  fields  falling  within  their  mandate  and  to  set  formats  and  controlled  vocabularies  for  data  and 
information they hold.  

3.  All agencies performing the assessment of chemicals should have an obligation to cooperate to prevent the 
divergent opinions and if divergent opinions appear, they should cooperate to solve it. A procedure for 
solving the divergent opinions should be specified.  

The best results in terms of strengthening the cooperation among the EU Agencies and  enabling coherence of 
scientific and technical work provided by the EU Agencies is achieved by implementing all three solutions.  
Requiring cooperation among the agencies on certain areas without providing a clear mandate for those areas 
would not achieve the desired objective. Providing a mandate to an agency for certain areas and not obliging 
the cooperation among agencies might lead to even more divergence.  

5.  STAKEHOLDER VIEWS  

A call for evidence for the initiative on making best use of EU agencies to streamline scientific assessments 
was published on the Commission website ‘Have your say’ on 15 March 2022. The public and stakeholders 
were invited to provide feedback on this initiative until 12 April 2022. In total, 65 submissions were received. 
Most  were  from  business  associations  and  companies  (in  total  around  70%  of  submissions),  followed  by 
submissions from EU citizens (11%), non-governmental organisations (6%), public authorities (6%), others (5 
%) and academic/research institutions (1.5%). Generally, there was a large support of the initiative among the 
respondents, whether of the ‘one substance, one assessment’ approach as a whole or of the specific initiative 
on  the  reattribution  of  tasks.  67%  of  respondents  expressed  their  explicit  support,  23%  did  not  expressed 
explicitly their opinion but provided relevant advices on how to develop the one substance, one assessment 
approach. About 10% expressed doubts about usefulness of the initiative or opposition to the initiative. 

As  the  call  for  evidence  was  the  first  public  consultation  on  an  initiative  under  the  one  substance,  one 
assessment, a lot of feedback received was not specific about the consulted initiative on the (re-)attribution of 
task to the EU Agencies but about the general scope of the one substance, one assessment approach as well as 
other initiatives announced under the one substance, one assessment. Annex II provides a summary of all the 
feedback received. 

Stakeholders  were  also  informed  and  consulted  on  the  reattribution  of  tasks  to  EU  agencies  during  the 
Information Session on One Substance, One Assessment with Stakeholders held on 1 June 2022. Some 800 
participants followed this on-line event. 

An extensive discussion on re-attribution of tasks to EU agencies was held with representatives of Member 
States and EU agencies at the meetings of the Expert Group on One Substance, One Assessment7 held on 2-3 
June 2022 and on 30 March 2023.   

Representatives of Member States and EU agencies participating in the expert group meetings were supportive 
to the initiative as well, providing concrete suggestions on the reattributions. 

The feedback regarding the (re-)attribution of tasks to the EU agencies received from the call for evidence and 
from Member States and EU agencies during meetings of the Expert Group on One Substance, One Assessment 
can be grouped in 6 areas and summarised as follows:  

•  Level of centralisation: Stakeholders and Member States suggested that re-attribution of work should not 
result in a single agency being responsible for the risk evaluations of all chemicals. The regulations must 
clearly set out the responsibilities of each agency.   

•  Expertise: Stakeholders suggested that reattributing tasks should be done based on the existing expertise 
available in the agencies to ensure that the agency receiving the task benefits from the necessary expertise. 
It should be ensured  that valuable expertise  acquired by existing  bodies  is preserved. Expertise  in  risk 
assessment under the different regulations should stay with those agencies currently responsible for them. 
Each  Agency  is  best  positioned  to  lead  and  carry  out  specific  assessments  because  of  their  extensive 
experience in product-specific matters, e.g., EFSA for food use and EMA for medicines use.  

•  Resources:  Member  States  insisted  that  the  new  tasks  for  the  agencies  must  be  accompanied  by  the 
required  resources.  Re-attributing  work  should  not  lead  to  an  agency  or  a  committee  being  unable  to 
manage the workload and jeopardise the quality of the work.   

10 

 
 
•  Organisation of scientific committees: Member State indicated that the agencies’ committees, especially 
of  ECHA,  might  need  to  be  reorganised  to  deal  with  increased  workload,  as  the  committee  for  risk 
assessment  of  ECHA  has  already  now  a  high  workload.  Instead  of  creating  new  scientific  panels  or 
committees,  the  agencies  should  preferably  reinforce  and  reuse  the  existing  panels,  committees  and 
expert/working groups. In any event, safety assessments should be performed by an independent panel, 
independent committee or expert group that is independent.   

•  Tasks to re-attribute: Some stakeholders and Member States suggested that the ECHA should be involved 
in hazard assessment as part of the assessment of food contact materials, and EFSA should be involved in 
risk  assessments.  The  agencies  should  be  involved  in  evaluating    cosmetic  ingredients,  deriving 
environmental  quality  standards  under  the  Water  Framework  Directive,  and  in  opinions  on  chemical 
substances in products (for example in toys).  

• 

Impact assessment: A few respondents from stakeholders suggested to carry out an impact assessment on 
the one substance, one assessment initiative to ensure that possible impacts on businesses are considered 
sufficiently and that businesses are involved in developing the initiative.  

6.  SCIENTIFIC  AND  TECHNICAL  WORK  ON  CHEMICALS  FOR  (RE-)ATTRIBUTION  TO  THE  EU 

AGENCIES AND STRENGTHENING THE COOPERATION AMONG THE AGENCIES 

Scientific and technical work on chemicals for (re-)attribution to the EU Agencies have been identified under 
36  pieces  of  legislation  or  work  packages  (see  Table  1  below).  The  tasks  for  (re-)attribution  have  been 
identified through the targeted inter-service consultation including the EU Agencies, targeted consultation with 
Member States and targeted consultation with stakeholders and by applying the guiding principles for the (re-
)attribution of scientific and technical work on chemicals to the EU Agencies (see section 4). The way how 
the tasks are (re-)attributed to the EU Agencies was discussed at length between the concerned Commission 
Service and the receiving Agency, taking into account the policy objectives, desired scientific rigour, scrutiny 
and technical and organisational feasibility. A particular attention was paid to the assessment of the proximity 
of a task for (re-)attribution with the Agency’s mandate and to the identification of potential synergies and 
added value of the (re-)attribution.  

There are various types of task (re-)attributions that have been proposed or are being considered (see ‘task 
type’  in  Table  1).  Reattribution  of  existing  tasks  from  a  non-agency  body  to  the  EU  Agencies  have  been 
proposed or are being considered to be proposed under 12 pieces of legislation or work packages. Out of these 
12 pieces of legislation or work packages, 3 contains reattributions that are accompanied with improvement or 
expansion of the reattributed tasks while 9 contains reattributions of tasks without their expansion. Attributions 
under 8 pieces of legislation or work packages are formalisation of the existing attributions of a task to an 
agency without a legal basis or are improvements of the specification of existing tasks. Attributions under 17 
pieces of legislation or work packages contain tasks that are new. Either they are extension of the tasks that 
already exists at the agencies or they are completely new tasks.  

The changes in the founding provisions of ECHA, EEA, EFSA and EMA to strengthen the cooperation among 
the agencies are listed here as a (re-)attribution, or improvement of the specification of existing tasks, under 
the respective founding regulations.  

The (re-)attribution of tasks have been already adopted for 5 pieces of legislation / work packages, and it was 
proposed  for  another  8  pieces  of  legislation.  The  (re-)attributions  are  still  to  be  proposed  for  20  pieces  of 
legislation/work packages and for 3 pieces of legislation the tasks are being defined and some of them might 
be suitable for attribution to the EU Agencies, but it is premature to conclude on this.  

Following the guiding principles, the highest number of tasks is to be (re-)attributed to ECHA, followed by 
EEA, EFSA, EMA and EU-OSHA. 

11 

 
 
 
 
 
 
14 

15 
16 
17 
18 

19 
20 
21 
22 
23 
24 
25 
26 

27 

28 

Receiving body 

Task type  

Table 1. Overview of legislation and work packages with tasks for (re-)attribution to the EU agencies 

Legislation/work packages with tasks for (re-)attribution  
Already adopted by the co-legislators  
Drinking water directive 
1 
Regulation on serious cross-border threats to health 
2 
European Partnership for the Assessment of Risks from Chemicals 
3 
Commission  implementing  decision  2022/1979  under  SEVESO 
4 
directive  
Batteries regulation 

ECHA 
ECHA, EEA, EFSA, EMA 
ECHA, EEA, EFSA 
             EEA 

ECHA 

E-PRTR regulation  
Industrial emissions directive 

5 
Already proposed by the Commission 
             EEA 
6 
ECHA 
7 
ECHA, EEA 
8  Water legislation (surface and ground water) 
ECHA,           EFSA 
9 
CLP regulation  
ECHA 
Packaging and packaging waste directive  
10 
                                  EMA 
11  Legislation on medicinal products for human use 
ECHA 
12  Directive on end-of-life vehicles 
13  Toys safety directive 
ECHA 
Proposed by the Commission as part of the package on one substance, one assessment 

Proposal for a directive for reattribution of tasks 
   RoHS directive 
Proposal for a regulation for reattribution of tasks 
   POPs regulation  
   Medical devices regulation  
   EEA founding regulation 
   General Food Law 
Proposal for a regulation establishing a common data platform and a 
monitoring and outlook framework for chemicals  
   Common Data Platform on Chemicals 
   Information Platform for Chemical Monitoring 
   Information on regulatory processes on chemicals 
   Repository of reference values 
   Information on the obligations under Union acts on chemicals 
   Environmental sustainability related data on chemicals 
   Data generation mechanism 
   Mechanism  for  notification  of  studies  &  database  for  study 

notifications 

ECHA 

ECHA, EEA 
ECHA 
             EEA 
                      EFSA 

ECHA, EEA, EFSA, EMA, OSHA 
ECHA, EEA, EFSA, EMA, OSHA 
ECHA, EEA, EFSA,            OSHA 
ECHA, EEA, EFSA, EMA, OSHA 
ECHA 
ECHA, EEA, EFSA, EMA, OSHA 
ECHA,           EFSA 
ECHA,           EFSA 

N 
RE 
N 
RE 

N 

REwE 
FE, EwE 
RE,N,EwE 
N, EwE 
EwE 
FE 
RE 
RE 

REwE 

REwE 
RE 
FE 
FE 

N 
RE, FE 
EwE 
N 
EwE 
N 
N 
N 

   Early  warning  and  action  system  for  emerging  chemical  risks  and 

ECHA, EEA, EFSA, EMA, OSHA 

N, EwE 

framework of indicators 

   Observatory  for  specific  chemicals  with  potential  contribution  to 

ECHA 

FE, EwE 

emerging chemical risks 
Planned to be proposed by the Commission 

Legislative proposal for a regulation on ECHA 
   Cooperation of ECHA with other EU agencies 
   Scientific opinions on occupational exposure limits 

29 
30 
31  REACH regulation 
32  Cosmetic products regulation  
33 
Tasks attribution considered 
34 
35  Tobacco products directive 
36  Regulation on fluorinated greenhouse gases and Regulation on ozone 

Scientific advice of SCHEER on non-chemical topics 

Sustainable product regulation  

ECHA 
ECHA 
ECHA 
ECHA 
SAM 

- 
- 
- 

FE 
FE 
EwE 
RE 
RE 

N 
N 
N 

depleting substances 

Legend: Colours are used to distinguish the legislative initiatives; N – attribution of a new task, EwE – existing task expanded; FE – 
formalisation of attribution of an existing task or better specification of an existing task, RE – reattribution of an existing task, REwE 
– reattribution of existing task and its expansion or improvement;  

A brief description of the tasks and work for (re-)attribution per legislation or work package, including the 
strengthening  the  provisions  for  cooperation  among  the  EU  Agencies,  is  provided  below  (for  detailed 
description see Annex III):  

12 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1.  Drinking water directive24 

Revision of the drinking water directive in 2020 attributed  new tasks to ECHA. ECHA is responsible for 
establishing and maintaining four EU positive lists for substances and compositions authorized to be used for 
the manufacturing of organic, cementitious, metallic and inorganic materials in contact with water intended 
for human consumption. ECHA first supports the Commission in compiling the first EU positive lists based 
on the national lists. Once established, ECHA will maintain the lists through the review of all the entries in the 
lists and then through the addition, removal and updating of the entries.   

2.  Regulation on serious cross-border threats to health25  

The new regulation on serious cross-border threats to health reattributed an existing task performed by the 
Scientific  Committee  on  Health,  Environmental  and  Emerging  Risks  (SCHEER)  to  ECHA,  EEA,  EFSA, 
EMA and also to the European Centre for Disease Prevention and Control and the European Monitoring Centre 
for Drugs and Drug Addiction. The regulation requires the agencies, on the request of the Commission, to 
carry out a risk assessment of the potential severity of the threat to public health, including possible public 
health measures when there is an alert of a cross-border threat of chemical origin. The responsibility for rapid 
risk assessment for risks of a cross-border threat that is linked to medicinal products and medical devices is 
assigned to the EMA, for risks of a cross-border threat of chemical origin is shared between the ECHA and the 
EFSA based on their mandate and for risk of a cross border threat of threats of environmental origin, including 
those due to the climate, are shared among the ECHA, the EFSA and the EEA based on their mandate. The 
agencies will have to set up and maintain a continuous readiness to provide rapid risk assessments and on the 
request provide the requested risk assessment.  

3.  European Partnership for the Assessment of Risks from Chemicals (PARC)26 

PARC  is  a  7-year  partnership  funded  by  Horizon  Europe  that  started  in  May  2022  and  aims  to  advance 
research, share knowledge and improve skills in chemical risk assessment.  ECHA, EEA and EFSA took a 
new task to provide input and support to the project in order to ensure maximum links with and benefits for 
the regulatory risk assessments of chemicals.  

4.  Commission implementing decision (EU) 2022/1979 under the SEVESO Directive27  

The commission implementing decision reattributed an existing task performed by the Commission (DG 
JRC)  to  EEA.  EEA  is  tasked  to  redevelop  and  maintain  the  databases  and  associated  procedures  for  the 
reporting of information on industrial major accidents (eMARS) and for reporting of the location of Seveso 
establishments (eSPIRS) under the SEVESO III directive. 

5.  Batteries regulation28   

The new regulation on batteries revising an old battery directive attributed a new task to ECHA. ECHA is 
tasked to prepare, on the request of the Commission, restriction dossiers for substances in  batteries, to get 
opinions  on  them  from  the  Committee  for  Risk  Assessment  and  from  the  Committee  on  Socio-Economic 
Analysis and to submit the opinions to the Commission for potential restrictions via a delegated act.  

24 Directive (EU) 2020/2184 of the European Parliament and of the Council of 16 December 2020 on the quality of 
water intended for human consumption (OJ L 435 23.12.2020, p. 1). 
25 Regulation (EU) 2022/2371 of the European Parliament and of the Council of 23 November 2022 on serious cross-
border threats to health and repealing Decision No 1082/2013/EU (OJ L 314 6.12.2022, p. 26). 
26 https://www.eu-parc.eu  
27 Commission Implementing Decision (EU) 2022/1979 of 31 August 2022 on establishing the form and databases for 
communicating the information referred to in Articles 18(1) and 21(3) of Directive 2012/18/EU of the European 
Parliament and of the Council on the control of major-accident hazards involving dangerous substances and repealing 
Commission Implementing Decision 2014/895/EU (OJ L 272 20.10.2022, p. 14). 
28 Regulation (EU) 2023/1542 of the European Parliament and of the Council of 12 July 2023 concerning batteries and 
waste batteries, amending Directive 2008/98/EC and Regulation (EU) 2019/1020 and repealing Directive 2006/66/EC 
(OJ L 191, 28.7.2023, p.1). 

13 

 
 
 
6.  E-PRTR regulation29  

The proposal for revision of the E-PRTR regulation proposes to expand the existing task of EEA to operate 
the European Pollutant Release and Transfer Register. EEA is tasked to operate an Industrial Emission Portal, 
which should replace the E-PRTR register and as compared to the E-PRTR should contain information on 
emissions for more substances and for more industrial activities and should contain also information on the 
use of water, energy and raw materials.  

7.  Industrial emissions directive30  

The proposal for the revision of the Industrial Emissions Directive proposes to  formalise existing task of 
ECHA performed at ad-hoc basis and extend it to cover holistic consideration of chemicals in the permits of 
the industrial emissions directive installations, from their presence in the (primary or secondary) raw materials 
to their presence in the emissions from the installations, as well as in the waste and by-products generated. 
ECHA  is  requested  to  support the  Commission in  the  review  of  the  Best  Available  Techniques  Reference 
(BREF) documents as regards the chemicals and industrial chemicals processes.  

8.  Water framework directive, Environmental Quality Standard Directive and Ground Water Directive31  

The proposal for the revision of the water framework directive, the environmental quality standard directive 
and the ground water directive proposes to reattribute existing tasks performed by the Commission and the 
Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) to ECHA, attribute a new 
task  to  ECHA  and  expand  the  existing  tasks  performed  by  EEA.  ECHA  and  its  Committee  for  Risk 
Assessment  are  requested  under  the  Environmental  Quality  Standard  directive  to  take  over  performing 
assessments underpinning the amendment of priority list of substances, derivation of Environmental Quality 
Standards,  amendment  of  the  ‘watch  list’  and  coordination  of  the  ‘watch  list’  activities.  ECHA  and  its 
Committee for Risk Assessment are requested under the Ground Water Directive to perform new assessments 
underpinning the review of Annexes I and II with limit values for chemicals in ground water, the amendment 
of ‘watch list’ and coordination of the ‘watch list’ activities. EEA is requested to expand its task on collection 
of  monitoring  data  in  surface  waters  and  to  harvest  all  chemical  monitoring  data  in  waters  generated  by 
Member States.  

9.  CLP Regulation32 

The proposal for revision of the CLP regulation proposes to attribute a new task to ECHA and EFSA and 
expand  the  existing  tasks  of  ECHA.  ECHA  and  EFSA  are  required  to  prepare,  on  the  request  of  the 
Commission, dossiers for harmonised classification of substances. ECHA’s Committee for Risk Assessment 
is then expected to prepare opinions on the dossiers prepared by ECHA or EFSA, which will be submitted to 
the Commission for potential amendment of Annex VI of CLP.  

10. Packaging and packaging waste directive33  

29 Proposal for a Regulation of the European Parliament and of the Council on reporting of environmental data from 
industrial installations and establishing an Industrial Emissions Portal (COM/2022/157 final). 
30 Proposal for a Directive of the European Parliament and of the Council amending Directive 2010/75/EU of the 
European Parliament and of the Council of 24 November 2010 on industrial emissions (integrated pollution prevention 
and control) and Council Directive 1999/31/EC of 26 April 1999 on the landfill of waste (COM (2022) 156 final). 
31 Proposal for a Directive of the European Parliament and of the Council amending Directive 2000/60/EC establishing 
a framework for Community action in the field of water policy, Directive 2006/118/EC on the protection of 
groundwater against pollution and deterioration and Directive 2008/105/EC on environmental quality standards in the 
field of water policy (COM(2022) 540 final) 
32 Proposal for a Regulation of the European Parliament and of the Council amending Regulation (EC) No 1272/2008 of 
the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures 
(COM (2022) 748 final). 
33 Proposal for a regulation of the European Parliament and of the Council on packaging and packaging waste, 
amending Regulation (EU) 2019/1020 and Directive (EU) 2019/904, and repealing Directive 94/62/EC (COM(2022) 
677 final). 

14 

 
 
 
The  proposal  for revision of  the  packaging  and  packaging  waste  proposes to  extend  the  scope  of  task  of 
ECHA  to  process  or  eventually  also  to  prepare  a  proposal  for  restriction  under  REACH  that  covers  or  is 
focused on a presence of a substance in packaging. Such restriction will be under the scope of REACH, so this 
relies on the existing REACH task. 

11.  Legislation on medicinal products for human use34,35  

The proposal for revision of the regulation and directive on medicinal products for human use proposes to 
introduce a new task and better specify existing tasks of EMA. EMA is required to actively cooperate with 
other EU Agencies as regards exchange of data, methodologies and scientific assessments. EMA is further 
required to engage more in preventing or solving a divergent opinion with other EU Agencies. The goal is to 
ensure  coherence,  consistency  and  interoperability  in  the  specified  areas.  EMA is  also  expected to receive 
marketing authorisation applications, like any other applications submitted to EMA, in electronic form and 
follow  the  digital  by  default  principle.  In  addition,  EMA  is  requested  to  set  up  an  active  substance  based 
monograph system from environmental risk assessments. 

12.  Directive on end-of-life vehicles36  

The proposal for the revision of the directive on end-of-life vehicles proposes reattribution of an existing 
task to ECHA. ECHA’s Committee for Socio-Economic Assessment will be required to provide assessments 
underpinning  review  of  exemption  from  existing  restriction  on  lead,  mercury,  cadmium  or  hexavalent 
chromium. ECHA is also required as part of REACH process to provide assessments underpinning restriction 
of hazardous substances in end-of-life vehicles. Such restriction will be under the scope of REACH, so this 
relies on the existing REACH task. 

13. Toy safety directive37 

The proposal for the revision of the toy safety directive proposes reattribution of existing tasks to ECHA 
and extending some of them. ECHA’s committees for risk assessment and socio-economic analysis is required 
to provide assessments underpinning the establishment or strengthening of chemical limit values in toys, the 
amendment of the limit values for heavy metals in toys, the amendments to the lists of allergenic fragrances 
that are prohibited in toys or that have to be labelled if present in toys and the granting of derogations for the 
use of carcinogenic, mutagenic and reprotoxic substances in toys.  

14.  Directive on restriction of hazardous substances (RoHS) in electrical and electronic equipment  

The proposal for amendment of the RoHS directive adopted as part the one substance, one assessment package 
proposes to reattribute the existing tasks performed by the Commission to ECHA and improve how those 
tasks are executed. ECHA is required to prepare, on the request of the Commission, a restriction dossier for 
substances  in  electrical  and  electronic  equipment.  Such  dossier  can  be  also  prepared  by  a  Member  State. 
ECHA’s Committees for Risk Assessment and for Socio-Economic Analysis are then requested to prepare an 
opinion on the restriction dossier (prepared by itself or by a Member State) and submit such opinions to the 
Commission. ECHA is also requested to receive applications for granting, renewing or revoking an exemption 

34 Proposal for a Directive of the European Parliament and of the Council on the Union code relating to medicinal 
products for human use, and repealing Directive 2001/83/EC and Directive 2009/35/EC (COM (2023) 192 final). 
35 Proposal for a Regulation of the European Parliament and of the Council laying down Union procedures for the 
authorisation and supervision of medicinal products for human use and establishing rules governing the European 
Medicines Agency, amending Regulation (EC) No 1394/2007 and Regulation (EU) No 536/2014 and repealing 
Regulation (EC) No 726/2004, Regulation (EC) No 141/2000 and Regulation (EC) No 1901/2006 (COM (2023) 193 
final).  
36 Proposal for a Regulation of the European Parliament and of the Council on circularity requirements for vehicle 
design and on management of end-of-life vehicles, amending Regulation (EU) 2018/858 and 2019/1020 and repealing 
Directives 2000/53/EC and 2005/64/EC (COM (2023) 451 final).  
37 Proposal for a Regulation of the European Parliament and of the Council on the safety of toys and repealing Directive 
2009/48/EC (COM(2023) 462 final). 

15 

 
 
 
 
from the substance restrictions, verify its completeness, get an opinion of its Committee for Socio-Economic 
Analysis and if necessary from its Committee for Risk Assessment and submit the opinions to the Commission.  

15.  POPs regulation 

The proposal for amendment of the POPs regulation via the omnibus regulation on (re-)attribution of tasks 
adopted  as  part  of  the  one  substance,  one  assessment  package  proposes  to  reattribute  the  existing  tasks 
performed by the Commission to ECHA and EEA and improve how those tasks are executed. On the request 
of the Commission, ECHA is expected to provide assessments underpinning setting concentration limit values 
for substances subject to waste management provisions as part of the review of Annexes IV and V of the POPs 
regulation. As part of that assessment, ECHA is required to prepare a report on the assessment with the proposal 
for concentration limit values, get opinion of its Committee for Socio-Economic Assessment on the report and 
submit the opinion to the Commission as an input for amendment of Annexes IV and V via the delegated act. 
EEA is expected to host the chemical monitoring data in the environment of the POPs listed in Annex III, Part 
I.  

16.  Medical devices regulation  

The proposal for amendment of the medical product regulation via the omnibus regulation on (re-)attribution 
of tasks adopted as part of the one substance, one assessment package proposes to reattribute the existing 
tasks performed by the Commission and its Scientific Committee on Health, Environmental and Emerging 
Risks (SCHEER) to ECHA. ECHA is required every 5 years to review the guidelines on how to perform the 
benefit-risk assessment of the presence of phthalates in medical devices. In addition, on the request of the 
Commission,  ECHA  is  required  to  prepare  and  review  the  guidelines  on  how  to  perform  the  benefit-risk 
assessment  of  the  presence  of  carcinogenic,  mutagenic,  reprotoxic  or  endocrine-disrupting  substances  in 
medical devices.  

17.  EEA founding regulation  

The proposal for amendment of the EEA founding regulation via the omnibus regulation on (re-)attribution of 
tasks adopted as part of the one substance, one assessment package proposes to better specify existing tasks 
of EEA. EEA is given a mandate to develop assessment methodologies related to chemicals within the mission 
of the agency and EEA is required to actively cooperate with other EU Agencies as regards exchange of data 
and development of methodologies. The goal is to ensure coherence, consistency and interoperability in the 
specified areas. 

18.  General Food Law 

The proposal for amendment of the General Food Law establishing EFSA via the omnibus regulation on (re-
)attribution of tasks adopted as part of the one substance, one assessment package proposes to better specify 
existing tasks of EFSA. EFSA is required to actively cooperate with other EU Agencies as regards exchange 
of data and development of methodologies. EFSA is further required to engage more in preventing or solving 
a divergent opinion with other EU Agencies. The goal is to ensure coherence, consistency and interoperability 
in the specified areas. 

19.  Common Data Platform on Chemicals  

The proposal for a regulation establishing a common data platform and a monitoring and outlook framework 
for chemicals adopted as part of the one substance, one assessment package assigns  new tasks to ECHA, 
EEA, EFSA, EMA and EU-OSHA. ECHA is requested to set up and operate the common data platform on 
chemicals, including the database of standard formats and controlled vocabularies. All agencies are requested 
to make the data on chemicals they hold available to the platform in appropriate formats for sharing among the 
authorities, to set formats and controlled vocabularies in their area of competence so data can be easily shared 
and to cooperate with ECHA and among each other in developing and operating the common data platform. 

20.  Information platform for chemical monitoring (IPCHEM) 

16 

 
 
The proposal for a regulation establishing a common data platform and a monitoring and outlook framework 
for  chemicals  adopted  as  part  of  the  one  substance,  one  assessment  package  proposes  to  reattribute  the 
existing task performed by the Commission to ECHA and EEA. ECHA is required to operate the IPCHEM 
as part of the common data platform on chemicals and host occupational monitoring data. EEA is requested to 
collect and host the human biomonitoring data and host environmental occurrence data and indoor air quality 
data.  The proposal will also  formalise the tasks of ECHA, EFSA, EEA, EMA and EU-OSHA to provide 
available chemical monitoring data to ECHA for integration into IPCHEM.  

21.  Information on regulatory processes on chemicals 

The proposal for a regulation establishing a common data platform and a monitoring and outlook framework 
for chemicals adopted as part of the one substance, one assessment package proposes to extend the existing 
task  currently  managed  by  ECHA.  ECHA  is  requested  to  continue  operating  the  (public)  activities 
coordination tool ((P)ACT) system and extend it to other pieces of legislation. EFSA,  EEA and EU-OSHA 
are required to provide the relevant information to ECHA.  

22.  Repository of reference values 

The proposal for a regulation establishing a common data platform and a monitoring and outlook framework 
for chemicals adopted as part of the one substance, one assessment package proposes a new task to ECHA, 
EFSA, EEA, EMA and EU-OSHA. ECHA is requested to set up, operate and populate with scientific and 
regulatory reference values a repository of reference values and to collate in it the regulatory reference values. 
EFSA, EEA, EMA and EU-OSHA are required to cooperate with ECHA in the operation of the repository 
and provide to ECHA the scientific reference values they derive. 

23.  Information on regulatory processes on chemicals   

The proposal for a regulation establishing a common data platform and a monitoring and outlook framework 
for chemicals adopted as part of the one substance, one assessment package proposes to formalise and expand 
the existing task ECHA is already carrying out with the EU chemicals legislation finder (EUCLEF). ECHA 
is  required  to  continue  the  operation  of  EUCLEF  and  extend  it  to  cover  all  relevant  legislative  pieces  on 
chemicals. 

24. Database on environmental sustainability related data 

The proposal for a regulation establishing a common data platform and a monitoring and outlook framework 
for chemicals adopted as part of the one substance, one assessment package proposes a new task to ECHA. 
ECHA  is  requested  to  set  up  and  operate  a  database  with  environmental  sustainability  data  on  chemicals. 
ECHA, EEA, EFSA, EMA and EU-OSHA are required to make available to the ECHA any environmental 
sustainability  related  data  they  host  or  hold.  The  agencies  also  need  to  provide  the  necessary  technical 
cooperation to ECHA to enable the integration of the data in the common data platform on chemicals.  

25. Data generation mechanism 

The proposal a regulation establishing a common data platform and a monitoring and outlook framework for 
chemicals adopted as part of the one substance, one assessment package proposes a new task to ECHA and 
EFSA. ECHA is required to commission studies in support of the implementation of chemicals legislation and 
to contribute to the support, evaluation or development of EU chemicals policy. ECHA is required to do it on 
its  own  initiative  or  on  the  request  of  the  Commission.  The  procedure  is  complementary  to  the  existing 
procedure operated by EFSA under Article 32 of the General Food Law and ECHA and EFSA should cooperate 
in designing and commissioning the studies under both procedures. 

26.  Mechanism for notification of studies and database for study notifications 

The proposal for a regulation establishing a common data platform and a monitoring and outlook framework 
for chemicals adopted as part of the one substance, one assessment package proposes a new task to ECHA. 
ECHA is required to set up a database of study notifications for studies beyond the food sector (i.e. for studies 

17 

 
 
not already subject to the notification obligation of Article 32b of the General Food Law and notified to EFSA). 
ECHA  and  EFSA  are  required  to  cooperate  to  ensure  compatibility  of  the  respective  systems.  ECHA  is 
expected to control fulfilment of the obligations to notify the studies as part of the compliance check under 
REACH and as part of approval of biocidal active substances and products.  

27.  Early warning and action system for emerging chemical risks and framework of indicators 

The proposal for a regulation establishing a common data platform and a monitoring and outlook framework 
for chemicals adopted as part of the one substance, one assessment package proposes a new task on an early 
warning and action system to EEA, ECHA, EFSA, EMA and EU-OSHA. It also proposes to formalise the 
existing task on an indicator framework performed by EEA and ECHA. For the early warning system, EEA 
is required to compile and collect annually the early warning signals into a report to be presented to the Member 
State  authorities,  relevant  EU  agencies  and  the  Commission  to  consider  whether  any  regulatory  action  is 
needed. ECHA, EFSA, EMA and EU-OSHA are required to cooperate with EEA and provide early warning 
signals from their areas of responsibility. For the framework of indicators, EEA and ECHA are required to 
operate and populate the indicator framework for chemicals policy. 

28.  Observatory for specific chemicals with potential contribution to emerging chemical risks 

The proposal for a regulation establishing a common data platform and a monitoring and outlook framework 
for chemicals adopted as part of the one substance, one assessment package proposes to formalise the existing 
task  performed  by  ECHA  and  expand  its  scope.  ECHA  is  required  to  continue  operating  the  existing 
observatory for nanomaterials and extend its scope to chemicals and materials of potential emerging risk.  

29.  Cooperation of ECHA with other EU agencies 

The proposal for the regulation on ECHA will consider proposing a new task to ECHA and better specify 
the  existing  tasks.  ECHA  should  be  given  a  formal mandate to  develop methodologies  for  assessment  of 
chemicals in the areas falling within its mission. ECHA should be required to actively cooperate with other 
EU Agencies as regards exchange of data and development of methodologies. Finally, ECHA should be further 
required to engage more in preventing or solving a divergent opinion with other EU Agencies. The goal is to 
ensure coherence, consistency and interoperability in the specified areas. 

30.  Scientific opinions on occupational exposure limits 

The proposal for the regulation on ECHA will consider to formalise the existing task of ECHA. ECHA and 
its  Committee  for  Risk  Assessment  should  be  given  a  legal  mandate  to  provide  opinions  on  occupational 
exposure limits in support of the Directive on carcinogens, mutagen or reprotoxic substances at work, Chemical 
Agent Directive and Asbestos Directive. ECHA already does so, but without a formal mandate and via a service 
level agreement with the Commission. 

31.  REACH regulation38 

The proposal for a REACH revision will consider proposing changes in the existing tasks of ECHA. ECHA 
should be required to implement the changed tasks. This should include expanded registration obligations (to 
polymers), changes in the restriction (expansion of the generic approach to risk management) and authorisation 
procedures and changes in enforcement provisions.  

32. Cosmetic products regulation39  

The  proposal  for  the  targeted  revision  of  the  Cosmetic  Products  Regulation  will  consider  proposing 
reattribution of existing tasks to ECHA. ECHA should be required to take over hosting of the Scientific 
Committee on Consumer Safety (SCCS) which assesses the safety of chemicals underpinning the process for 
the  authorisation  of  colorants,  preservatives  and  UV-filters,  the  process  for  prohibition  or  restriction  of 
ingredients used in cosmetic products where concerns are raised due to potential risks to human health, the 

38 Chemicals legislation – revision of REACH Regulation to help achieve a toxic-free environment (europa.eu) 
39 EU chemicals strategy for sustainability – Cosmetic Products Regulation (revision) (europa.eu) 

18 

 
 
 
process for granting an exemption from the prohibition of chemicals that cause cancers, gene mutations, affect 
the reproductive or endocrine system and the process for examining the safety of substances used in cosmetic 
products  that  could  affect  the  respiratory  system  and  chemicals  toxic  to  a  specific  organ.  ECHA  and  its 
committee should be also required to produce a technical guidance document concerning different aspects of 
testing and safety evaluation of cosmetic substances including for nanomaterials used is cosmetics. 

33. Non-chemical assessments performed by SCHEER 

The Commission Decision on discontinuing the operation of scientific committees SCHEER and SCCS will 
result in reattribution of existing tasks to the Commission Scientific Advisory Mechanism (SAM). SAM 
will be required on the ad hoc basis to provide a scientific advice on non-chemical topics currently provided 
by SCHEER.  

34. Ecodesign for sustainable products regulation40  

The proposal for regulation on eco-design for sustainable products envisages some new tasks that could be 
potentially attributed to EU Agencies. These tasks are not defined in the proposal but rather to be specified in 
the envisaged implementing acts. Such envisaged tasks include involvement of ECHA in the development of 
a product passport that should hold also information on substances of concern.  

35. Tobacco products directive41 

The tobacco directive is undergoing an evaluation and a revision of the directive is being envisaged. As part 
of the revision, a new scientific and technical work is being envisaged that could be potentially attributed to 
EU Agencies. This includes managing the laboratory network on tobacco control, checking compliance with 
product  presentation  provisions,  running  the  procedure  determining  characterizing  flavour,  updating 
negative/positive  lists  of  additives,  hosting  product  database  and  making  publicly  available  the  product 
information, monitoring of data in product notifications and assessing information on leaflets. The tasks are 
not yet clear but those that are being considered do not naturally fit to the agencies considered in this initiative.  

36. Regulation on fluorinated greenhouse gases42 and the Regulation on ozone depleting substances43  

The proposal for a regulation on fluorinated greenhouse gases  establishes an obligation on the Commission to 
operate an electronic system for the management of the quota system, licensing of imports and exports and 
reporting  and  introduces  invoicing  fees  for  the  quotas.  Similarly  for  the  Regulation  on  ozone  depleting 
substance, the Commission has the obligation to operate a licencing and reporting system.  It is not yet clear 
how the tasks can be implemented most effectively, but it is envisaged that an agency could take some of the 
tasks in case that would be deemed to be the best option at a later stage.  

7.  ASSESSMENT OF IMPACTS  

The fitness check of all chemical legislation (excluding REACH) assessed most of the challenges and risks 
addressed through this  initiative  and  concluded  that there  are significant  opportunities for  streamlining the 
technical and scientific work through EU agencies. Moreover, there is little discretion of the policy choice as 
to achieve objectives of the initiative. The consolidation of the technical and scientific work on chemicals at 
the EU level is possible only in the EU Agencies. Therefore, no formal impact assessment was carried out. 

Overall impact 

Although no formal assessment of social, economic and environmental impacts was carried out, such impacts 
were qualitatively assessed by the Commission with the help of external consultants. The outcomes of the 

40 Proposal for a Regulation of the European Parliament and of the Council establishing a framework for setting eco-
design requirements for sustainable products and repealing Directive 2009/125EC (COM (2022) 142 final). 
41 Evaluation of the legislative framework for tobacco control (europa.eu)  
42 Proposal for a Regulation of the European Parliament and of the Council on fluorinated greenhouse gases, amending 
Directive (EU) 2019/1937 and repealing Regulation (EU) No 517/2014 (COM (2022) 150 final). 
43 Proposal for a Regulation of the European Parliament and of the Council on substances that deplete the ozone layer 
and repealing Regulation (EC) No 1005/2009 (COM (2022) 151 final).  

19 

 
 
 
assessment is  provided  in  the  sub  section  ‘overall impact’  of the  section 8  for the  legislative  proposals  on 
reattribution of tasks and of the section 9 for the legislative proposal for a regulation establishing  a common 
data  platform  and  a  monitoring  and  outlook  framework  for  chemicals.  The  overall  impacts  from  all 
reattributions are summarised in the section 10.1. ‘added value and synergies of the (re-)attributions’.   

Assessment of impacts on resources and committees of EU agencies  

As the (re-)attribution of tasks to EU agencies will have a major impacts on their resource and capacity needs, 
these impacts were assessed in great detail. Assessment of impacts of the (re-)attribution of each task to the 
EU  Agencies  included  assessment  of  synergies  and  added  value  of  the  (re-)attribution,  estimation  of  the 
impacts  on  Agencies’ committees,  data  model and  IT  infrastructure  and  key experts  and  estimation  of  the 
workload  and  associated  resource  needs  for  the  Agencies.  For  the  existing  tasks  to  be  reattributed,  the 
assessment also included description of the current workload and estimation of the current use of resources. 
The detailed assessment of impacts for each task per legislation or work package is provided in Annex III.  

The estimation of the current resource use included an estimation of the full time equivalents dedicated to the 
tasks. This consisted of the estimation of the full time equivalent of the Commission staff as well as estimation 
of  the  full-time  equivalents  of  the  contracted  staff  (external  and  intramurous  consultant,  interim  staff).  To 
convert the cost of consultants into full time equivalents, the cost of 1 full time equivalent of a consultant was 
estimated based on the contracts and average Belgium salary at ca. EUR 66 000 annually44. It should be noted 
that the estimation of full-time equivalents for the Commission staff does not include administrative or IT 
overhead of the Commission.  

The estimation of the resource needs for the Agencies was done in close and frequent consultation with the 
Agencies  concerned.  The  operation  of  each  (re-)attributed  task  to  Agencies  has  been  assumed  to  be  done 
through implementing similar processes and similar level of scientific scrutiny and digitalisation to what is 
already in place for Agencies’ current tasks. The benefit of this approach is to ensure a consistent standard of 
scientific quality, transparency and data interoperability as well as to maximise the reuse of existing processes 
and tools. In general, internal experts were assumed to be used for scientific and technical work underpinning 
assessments  related  to  chemicals  and  the  agencies’  committees  to  be  used  to  validate  the  work  through 
provisions of opinions. External contracting was envisaged for the IT development as well as for the collection 
of data or information.  

ECHA is the agency to receive most of the assessment work on chemicals. The estimation of the resource 
needs for the new assessment task to be allocated to ECHA was built on the ECHA’s experience of the resource 
needs for their existing processes. The experience shows that resource requirement for the development of an 
opinion on harmonised classification varies between 0.35 – 0.65 FTEs per dossier (0.35 for low complexity 
dossier,  0.5  for  average  complexity  and  0.65  FTE  for  complex  dossier),  for  scientific  opinion  on  the 
occupational exposure limit values is average of 0.7 FTE per dossier, for opinion on REACH authorisation is 
0.15 FTE pre dossier of low complexity up to 0.35 FTE per dossier of high complexity, for opinion on REACH 
restriction is 1 FTE per dossier of low complexity up to 1.5 FTE per dossier of high complexity. An overhead 
of 15% was added to the resource estimate for the development and maintenance of common IT components 
and  additional  15%  for  the  contribution  to  the  horizontal  support  (governance  &  enablers  /  administrative 
overhead).  

8. 

IMPACTS OF THE LEGISLATIVE PROPOSALS ON REATTRIBUTION OF TASKS  

Overall impact 

Overall, this proposal is expected to improve the efficiency, effectiveness, coherence and transparency of EU 
processes  for  chemical  assessments  for  the  benefit  of  all  stakeholders.  Citizens  and  the  environment  will 
benefit from better protection from dangerous chemicals as a result of more efficient and effective assessment 
processes. Companies will benefit from more harmonised and transparent processes across legislation, from a 

44 This number corresponds to a medium to high BE annual salary cost (see e.g. An overview of Belgian wages and 
salaries | Statbel (fgov.be)); Belgian average salaries were used because many companies contracted by the Commission 
are based on Belgium.  

20 

 
 
 
reduced  number  of  bodies  involved  in  safety  and  risk  assessments,  as  well  as  from  strengthened  certainty 
regarding  the  validity  of  assessments.  Finally,  the  national  and  EU  authorities  will  benefit  from  improved 
efficiency of delivery of assessments and improved public trust and acceptance of regulatory decisions. 

•  Improved  scientific  consistency  and  coherence  of  assessments  –  The  reduced  number  of  actors 
involved in the scientific and technical work, as well as an increased cooperation and obligation to solve 
divergent opinions among agencies leads to improved coherence and scientific consistency - both across 
the various Union acts, and across the assessment processes laid out therein. The consolidation of work 
allows to better align priority setting, timelines, processes, and methodologies used for the assessments. 
It facilitates re-use of assessment insights developed under one Union act on chemicals in the assessment 
process of another.  

•  Improved  robustness  of  assessment,  trust  and  acceptance  of  regulatory  decisions  –  The 
involvement of the EU agencies and their committees in the scientific and technical work on chemicals 
adds more scientific expertise, ensures high quality of scientific advice and leads to improved robustness 
of assessments and thus their acceptance.  

•  Strengthen independence of the scientific advice – Moving scientific and technical work on chemicals 
from the Commission, ad hoc committees or consultants to EU agencies and their committees reinforces 
the independence of the scientific advice and the separation between science and policy or between risk 
assessment  and  management.  Agencies  are  independent  and  their  committees  work  under  stricter 
conflict  of  interest  avoidance  rules,  improving  guarantees  of  independent  scientific  advice  to  the 
Commission. 

•  Improved transparency – The involvement of the EU agencies in scientific and technical work will 

ensure transparency to the process in terms of overall process transparency. 

•  Improved efficiency of delivery of assessments – Centralising assessment work in the EU agencies 
will allow the re-use of capabilities, the re-use of knowledge and experience, and the re-use of IT tools 
and support services. 

Impact on resources of Agencies and the Commission 

The proposal for a directive on reattribution of tasks will amend RoHS directive to reattribute the assessment 
work  under  this  directive  to  ECHA.  The  proposal  for  a  regulation  on  reattribution  of  tasks  will  amend  2 
legislative pieces (POPs Regulation and Medical devices regulation) to reattribute the assessment work under 
these pieces of legislation to ECHA and it will amend the EEA founding regulation and the general food law 
(EFSA founding regulation) to ensure better cooperation among agencies on methodology development and 
on exchange of data. In summary for these two proposals on reattribution, in the first year, there will be a need 
of 4 FTEs (4 TAs) and operational costs of EUR 101 000 per year and as of the second year, there will be a 
need of 9 FTEs (6 TA + 3 CA) per year and operational budget of EUR 83 000 per year. All new resources 
are  needed  for  ECHA,  no  additional  resources  are  needed  for  EEA  and  EFSA.  Considering  the  resources 
currently used for the tasks to be reattributed, there will be a total net increase in the resources from 2026 and 
beyond as compared to today of 4.5 FTEs per year and EUR 59 000 per year. 

Table 2. Resource needs per legislation amended via the directive and regulation on reattribution of tasks (operational costs 
in EUR 1 000) 

FTEs 

Operational costs 

Legislation 

2025 

2026 

2027 

2028 

2025 

2026 

2027 

2028 

TA  CA  TA  CA  TA  CA  TA  CA 

Proposal for a directive on reattribution of scientific and technical work 

RoHS directive  

3 

0 

4 

3 

4 

3 

4 

3 

66 

Proposal for a regulation on reattribution of scientific and technical work  

POPs regulation  

Medical devices regulation  

EEA founding regulation  

1 

0 

0 

0 

0 

0 

2 

0 

0 

0 

0 

0 

2 

0 

0 

0 

0 

0 

2 

0 

0 

0 

0 

0 

35 

0 

0 

33 

50 

0 

0 

33 

33 

50 

0 

0 

50 

0 

0 

21 

 
 
 
 
 
 
 
 
General  food  law  (EFSA  founding 
regulation) 
SUM 

0 

4  

0 

0 

0 

6 

0 

3 

0 

6 

0 

3 

0 

6 

0 

3 

0 

101 

0 

83 

0 

83 

0 

83 

Table 3. Current resource use for technical and scientific work to be reattributed to ECHA 

RoHS directive 
• Assessments underpinning restrictions of  hazardous 
substances in electrical and electronic equipment  

• Review of applications for exemptions from the restrictions 

POPs regulation 
• Technical assistance in reviewing Annexes IV and V  
• Hosting POPs monitoring data  

Medical devices regulation  
• Preparation and review of the guidelines on how to perform 
the benefit-risk assessment of the presence of phthalates in 
medical devices 

• Preparation and review of the guidelines on how to perform 
the benefit-risk assessment of the presence of CMR and 
endocrine-disrupting substances in medical devices 

SUM 

Total ca. 2.74 FTEs/year: EUR 145 000 annually (on average) for 
outsourcing the review of exemptions (= ca. 2.2 FTEs/year) + a 
contract of EUR 180 000 on average each 5 years for reviewing 
restrictions (= 0.54 FTE/year). (In addition, DG ENV ca. 1.5 
FTE/year (for overall RoHS implementation) whose work will 
remain). 

Total ca. 1.5 FTEs/year: EUR 300 000 for consultants every 3 
years (=1.5 FTE/year). (In addition, DG ENV ca. 0.5 FTE/year 
(implementing the review of Annexes IV and V) whose work will 
remain). 

Total ca. 0.3 FTE/year + EUR 24 000/year: DG SANTE SCHEER 
secretariat 0.3 FTE (ca. 10% of SCHEER secretariat work), EUR 
24 000/year for indemnities, travel, e.g. costs for members of the 
committee. (In addition, DG SANTE (policy unit) 0.1 FTE/year 
whose work will remain).  

0.3 FTEs/year of regular staff; 4.2 FTEs/year of intramurous 
contractors or interim staff (ca. EUR 281 000/year); 
Operational costs of ca. EUR 24 000/year 

Changes to RoHS directive will reattribute the assessments underpinning restrictions of hazardous substances 
in  electrical  and  electronic  equipment  and  review  of  applications  for  exemptions  from  the  restrictions  to 
ECHA. For this work, ECHA will require in the first year 3 FTEs (3 TAs) and operational budget of EUR 66 
000 and as of the second year 7 FTEs (4 TAs + 3 CAs) per year and operational budget of EUR 33 000 per 
year. The work is currently performed with the help of consultants and amounts to approximately 2.74 FTE 
per year (ca. EUR 145 000 annually for outsourcing the review of exemptions (ca. 2.2 FTEs/years) + ca. EUR 
180 000 every 5 years for contracts to review restrictions (ca. 0.54 FTE/year)). DG ENV uses ca. 1.5 FTE of 
core staff for overall RoHS implementation, which will need to continue. The resources currently spent are 
however insufficient leading to the accumulation of requests for exemptions without processing them to the 
legal drafting (by December 2022, over 60 exemption requests were pending) and the revision of the restriction 
was delayed (the review not finalised although it has started in 2018). There are also complaints about the 
quality and robustness of the assessments, the transparency of the process and involvement of stakeholders. 
The reattribution to ECHA and using its processes will address these shortcomings and will ensure alignment 
with other chemicals legislation.  

Changes to POPs regulation will reattribute the technical assistance in reviewing Annexes IV and V to ECHA 
and hosting the POPs monitoring data to EEA. For this work, ECHA will require in the first year 1 FTE (1 
TA) and operational budget of EUR 35 000 and as of the second year 2 FTEs (2 TAs) per year and operational 
budget of EUR 50 000 per year. No resources are needed for EEA. The work on reviewing the Annexes IV 
and V is currently performed by the Commission with the help of consultants and amounts to approximately 
1.5  FTEs  per  year  (EUR  300 000  for  consultants  every  3  years  (=1.5  FTE/year)).  DG  ENV  uses  ca.  0.5 
FTE/year of core staff for implementing the review of Annexes IV and V, which will however need to continue. 
The  involvement  of  ECHA  and  its  Committee  for  Socio-Economic  Analysis  is  envisaged  to  provide  a 
significant increase in the scientific quality, the consistency, the robustness and the level of independence of 
the assessments upon which the Commission develops its proposals on this matter. The hosting of chemicals 
monitoring data under the POPs regulation is currently done by the Commission. Transfer of this work to EEA 
will require no additional resources, as POPs monitoring data in waters are to be reported to EEA under the 
water legislation and resources for that were proposed in the recent proposal, the POPs monitoring data in air 
are already being reported to EEA as part of the air quality legislation and covered by resources for that activity. 

22 

 
 
 
 
In addition, hosting of any additional data sets in the environment is also covered in the resource for common 
data platform. 

Changes to medical devices regulation will not require any additional resources for ECHA. The work is 
currently performed by the Commission supported by the SCHEER committee. The current resource use is 
estimated to be 0.3 FTE per year and EUR 24 000 per year (DG SANTE SCHEER secretariat 0.3 FTE (ca. 
10% of SCHEER secretariat work), EUR 24 000 per year for indemnities, travel, e.g. costs for members of the 
committee). DG SANTE uses (policy unit) uses ca. 0.1 FTE of core staff per year for implementation of the 
related provisions, which will however need to continue. Considering that the envisaged frequency of the work 
is  very  low,  the  involvement  of  the  Committees  is  only  where  necessary  and  the  first  work  will  likely 
materialise only in 2029, the work can be absorbed by ECHA without any additional resources. 

Changes to the regulation on the European Environment Agency and to the regulation on the general 
principles and requirements of food law and establishing the European Food Safety Authority will have 
no  resource  implications.  The  provisions  formalise  the  activities  already  performed,  they  prescribe  the 
procedural steps to follow and they enable the implementation of the proposal for a regulation establishing a 
common data platform on chemicals, laying down rules to ensure that the data contained in it are findable, 
accessible, interoperable and reusable and establishing a monitoring and outlook framework for chemicals. 
Any possible resource needs stemming from these provisions can be absorbed by the existing resources of the 
agencies. 

Impact on committees of Agencies 

There will be an impact on ECHA’s committees for risk assessment and for socio-economic analysis. It is 
estimated that the committee for risk assessment will have to process ca. 4 opinions per year: one opinion 
on new restriction of a substance (which is of equivalent of low complexity restriction under REACH) and 3 
opinions  per  year  on  requests  for  new  exemptions  (which  is  expected  to  be  lighter  dossier  than  the  low 
complexity restriction dossier under REACH) under RoHS. The committee for socio-economic analysis is 
expected to process ca. 33 opinions per year: 1 opinion on restriction of a substance and 30 opinions on the 
requests for exemption under RoHS, and 2 opinions on the revision of Annex IV and V and the proposed limit 
value under the POPs regulation. 

Table 4. Expected number of opinions from ECHA’s committees per year and per legislation 

RoHS directive 

-  Restriction  
-  Request for exemption  

POPs regulation 

-  Review of Annexes IV and V  

SUM 

RAC 

SEAC 

1 
3 

- 
4  

1 
30 

2 
33 

9. 

IMPACT OF THE LEGISLATIVE PROPOSAL FOR A REGULATION ESTABLISHING A COMMON DATA 
PLATFORM AND A MONITORING AND OUTLOOK FRAMEWORK FOR CHEMICALS  

Overall impact 

Overall, this proposal is expected to contribute to an improvement of the efficiency, coherence, quality and 
transparency of chemicals assessments under EU legislation as well as to the early identification of emerging 
chemicals risks. It will therefore improve the protection of human health and the environment from chemicals, 
for  the  benefit  of  Member  State  authorities,  stakeholders  and  citizens.  In  addition,  the  initiative  simplifies 
access  to  chemicals  information  for  everyone  (citizens,  industry,  national  authorities,  EU  agencies,  the 
Commission) thus increasing transparency. Moreover, it will improve predictability and thus the possibility 
for the industry, national authorities and EU agencies to plan – and where relevant coordinate – their activities: 

•  Bringing together chemicals data in one common data platform will increase findability and simplify 
access,  which  is  beneficial  for  all  users.  The  platform  will  operationalise the  ambition  of  the  one-
substance  one-assessment  approach,  supporting  quality  and  mutual  coherence  of  chemicals 

23 

 
 
 
 
assessments. The use of standard formats and controlled vocabularies will enhance interoperability of 
information, thus increasing its findability. In addition, information across regulatory dossiers will be 
easier to compare. An increased findability and comparability will in turn reduce administrative burden 
for  risk  assessors,  which  include  national  administrations,  and  have  a  positive  impact  on  the 
effectiveness, efficiency and coherence of chemical safety assessments.   

•  Through the extended utility of shared information in the common data platform, this proposal will 
help  minimise  potential  duplication  of  efforts  and  optimise  data  generation  strategies.  With  an 
increased volume and transparency of data on chemical properties and supported by adequate context 
data  that  enables  the  responsible  use  of  that  chemicals  data,  compliance  with  and  enforcement  of 
existing obligations should be facilitated.  

•  Building on integrated access and services the common data platform is expected to provide additional 
insight into effective risk management measures and to facilitate the search for safe and sustainable 
alternatives, leading to improvements in the protection of human health and the environment. 

•  Bringing together chemicals data and being allowed to use it will increase the knowledge base for 
scientific assessments and opinions, thus improving their robustness. This will in turn increase the 
acceptance by society of conclusions and regulatory decisions. Knowing through the notification of 
studies that all studies have been considered in an assessment further strengthens the trust of citizens 
in regulatory decisions.   

•  A  dedicated  service  in  the  common  data  platform  related  to  information  on  regulatory  processes 
planned  or  ongoing  by  the  Commission,  EU  agencies  and  Member  States  will  improve  the 
coordination of activities, which in turn will allow better planning for the authorities and agencies 
involved, thus increasing efficiency. That information will also allow better predictability and planning 
for industry,  facilitating  receipt  of  comprehensive  but  also  consistent  input to the  activities,  where 
required. It will be easier for industry but also other stakeholders to know when and how to contribute 
to regulatory processes. 

•  A  dedicated  service  in  the  common  data  platform  related  to  obligations  under  EU  legal  acts  on 
chemicals will be very valuable for industry, and in particular for SMEs and microenterprises, to easily 
get an overview of their legal obligations, which will give them certainty on what exactly their duties 
are. Acting with such full knowledge in turn supports compliance and correspondingly reduces burden 
on national authorities. 

•  The  establishment  of  a  monitoring  and  outlook  framework  including  an  early  warning  and  action 
system for emerging chemical risks will allow to shorten the reaction time between early signals of 
risks and regulatory measures to reduce those rusks, and as such will lead to an improved protection 
of human health and the environment. 

•  The establishment of a data generation mechanism allows the commissioning of studies when there 
are no legal provisions to obtain them. This will contribute to the creation of a complete knowledge 
base. 

The establishment and operation of the platform will not impose any costs on industry. Economic operators 
will continue to have to fulfil their legal obligations as they are doing today under the relevant specific pieces 
of legislation. Economic operators and laboratories will experience some administrative burden linked to the 
requirement to submit a notification when a study is intended to be commissioned or carried out. Quantified 
costs associated with the notification obligation are set out in the staff working document accompanying this 
proposal45. 

The establishment of the platform will be associated with significant costs for the EU agencies, but they should 
principally  be  seen  as  investment  in  technical  progress  within  the  data  economy,  enhancing  the  value  of 
existing  and  future  data.  The  task  requires  investment  in  entirely  new  data  structures  and  IT 

45 Commission staff working document accompanying the document Proposal for a Regulation of the European 
Parliament and of the Council establishing a common data platform on chemicals, laying down rules to ensure that the 
data contained in it are findable, accessible, interoperable and reusable and establishing a monitoring and outlook 
framework for chemicals.  

24 

 
 
 
systems/capabilities, principally on the ECHA’s side, but also on the side of other EU agencies as data source 
owners who are to prepare datasets for integration in the platform.  

Impact on resources of Agencies and the Commission 

The legislative proposal for a regulation establishing a common data platform and a monitoring and outlook 
framework for chemicals consists of 10 distinct activities that will have an impact on the resource needs of 
ECHA, EEA, EFSA, EMA and the Commission. The first three years there will be a need for up to 32 FTEs 
(12 TA + 20 CA) per year and an operational budget of up to EUR 8 657 000 per year. In the fourth year 
and beyond, there will be a need of 20 FTEs (12 TAs and 8 CA) per year and EUR 7 080 000 per year. 
Considering the resources currently used for the existing tasks to be reattributed (i.e. resources for IPCHEM), 
there will be a total net increase in the resources in the fourth year and beyond as compared to today of 15.5 
FTEs per year and operational budget of EUR 7 080 000 per year. 

Table 5. Resource needs per activity of the legislative proposal for a regulation establishing a common data platform and 
a monitoring and outlook framework for chemicals (operational costs in EUR 1 000) 

Activity  

2025 

2026 

2027 

2028 

2025 

FTEs 

Operational costs 
2027 

2026 

2028 

Common data platform 

for  Chemical 

Information  Platform 
Monitoring (IPCHEM) 
Information  on  regulatory  processes  on 
chemicals 
Repository of reference values  

Information  on  the  obligations  under 
Union acts on chemicals 
Environmental  sustainability  related  data 
on chemicals 
Data generation mechanism 
Mechanism for notification of studies and 
database for study notifications 
Early  warning  and  action  system  for 
emerging chemical risks and framework of 
indicators 
Observatory  for  specific  chemicals  with 
potential 
emerging 
chemical risks 
SUM 

contribution 

to 

TA  CA  TA  CA  TA  CA  TA  CA 
4 

16 

16 

16 

5 

5 

5 

5 

1 

0 

1 

0 

0 

1 
1 

1 

0 

0 

0 

0 

0 

0 
2 

0 

2 

0 

1 

0 

1 

1 
1 

1 

1 

0 

0 

0 

0 

1 
2 

0 

2 

0 

1 

0 

1 

1 
1 

1 

1 

0 

0 

0 

0 

1 
2 

0 

2 

0 

1 

0 

1 

1 
1 

1 

1 

0 

0 

0 

0 

1 
2 

0 

0 

0 

0 

0 

0 

0 

0 

0 

950 

3 442 

4 077 

1 300 

0 

0 

0 

0 

0 

0 
0 

0 

0 

200 

380 

230 

0 

0 

0 

650 

650 

200 

0 

0 

0 

0 

0 

0 

1 000 
1 200 

3 000 
400 

5 000 
200 

300 

150 

150 

0 

0 

0 

10   18 

12 

20 

12 

20 

12 

8 

950  

6 792 

8 657  

7 080 

Table 6. Current resource use for existing activities that are (re-)attributed 

IPCHEM 

Information on regulatory 
processes on chemicals 

Information on the obligations 
under Union acts on chemicals  

Observatory for specific 
chemicals with potential 
contribution to emerging 
chemical risks  
SUM 

Total 4.5 FTEs/year: DG JRC staff 2.5 FTEs/year + IT experts intramurous 2 FTEs/year (EUR 130 
000 per year). 

ECHA already operates (P)ACT for REACH, CLP and POPs processes. EFSA already operates 
OpenEFSA which has a similar level of information as PACT. Resources for the operation and 
continuous provision of information are to be absorbed by the Agencies. 

ECHA already operates EUCLEF and this is financed through the contribution agreement between 
DG GROW and ECHA: Total ca. EUR 1.0 - 1.4 million annually, with no posts. ECHA runs the 
service through the employment of 4 interim staff members (ca. EUR 270 000/year) and via 
contractors: communication activities and external helpdesk ca. EUR 60 000/year, IT costs EUR 
200 000/year, data costs EUR 430 000/year. No additional resources needed but the formalisation 
of the resource allocation should be done via the proposal for a regulation on ECHA.  
ECHA already operates the EU Observatory on Nanomaterials and this is financed via a 
contribution agreement between DG GROW and ECHA: Total of EUR 700 000 annually including 
3 CAs/year. No additional resources needed but the formalisation of the resource allocation should 
be done via the proposal for a regulation on ECHA. 
2.5 FTEs/year of regular staff; 2 FTEs/year of intramurous contractors or interim staff (ca. 
EUR 130 000 per year) 

25 

 
 
 
 
 
 
 
 
 
 
 
 
The highest attribution of resources is necessary for ECHA,  both in terms of FTEs and operational budget, 
followed by EEA, EFSA and EMA. After initial higher numbers for the first three years (2025-2027), as of the 
fourth year ECHA will need 13 FTEs (9 TA + 4 CA) and an operational budget of EUR 6 180 000 per year, 
EEA will need 3 FTEs (3 TAs) and EUR 400 000 per year, EFSA will need 2 FTEs (2 CA) and EUR 500 
000 per year, EMA will need 2 FTEs (2 CAs) and EUR 0 per year and JRC 0 FTEs and EUR 0 per year. No 
additional resources are required for EU-OSHA. 

 Table 7. Resource needs per agency (operational costs in EUR 1 000) 

Agency / Service 

2025 

ECHA 
EEA 
EFSA 
EMA 
EU OSHA 
JRC 
SUM 

TA 
7 
3 
0 
0 
0 
0 
10  

CA 
8 
2 
5 
3 
0 
0 
18 

2026 
TA  CA 
10 
2 
5 
3 
0 
0 
20 

9 
3 
0 
0 
0 
0 
12 

FTEs 

2027 

2028 

2025 

Operational costs 
2027 

2026 

TA 
9 
3 
0 
0 
0 
0 
12 

CA 
10 
2 
5 
3 
0 
0 
20 

TA 
9 
3 
0 
0 
0 
0 
12 

CA 
4 
0 
2 
2 
0 
0 
8 

0  
0  
670  
100  
0 
180  
950 

5 076  
766 
670  
100  
0 
180  
6 792 

7 023  
684  
670  
100  
0 
180  
8 657  

2028 

6 180  
400  
500  
0  
0 
0  
7 080 

Common Data Platform will be established and operated by ECHA with close involvement and contribution 
from EEA, EFSA, EMA, EU-OSHA and the Commission. The work will include development and operation 
of the infrastructure and the governance and provision of data into the platform. The principal aim of new IT 
infrastructure operating as part of the Green Deal Data Space is to support effective and coherent chemical 
safety assessments. It shall provide integrated, user-differentiated and highly functional access to chemicals-
related datasets owned or managed by EU agencies and provide space for the dedicated services supporting 
EU chemicals policy and legislative implementation. The work will require resources for 4 agencies involved 
and the Commission (JRC). The resource requirement is higher for the first 3 years to set up the infrastructure 
and all the underlying processes to share the data and make them interoperable and in adequate formats. This 
will require for the first 3 years: 

• 

• 

• 
• 
• 
• 

for ECHA, 10 FTEs (4 TAs + 6 CAs) per year and operational budget of EUR 0 for the first 
year, EUR 2 226 000 for the second year and EUR 2 793 000 for the third year; 
for EEA, 3 FTEs (1 TA + 2 CAs) per year and operational budget of EUR 0 for the first year, EUR 
266 000  for the second year and EUR 334 000 for the third year; 
for EFSA, 5 FTEs (5 CAs) per year and an operational budget of EUR 670 000 per year;  
for EMA, 3 FTEs (3 CAs) per year and an operational budget of EUR 100 000 per year;  
for EU-OSHA, 0 FTEs per year and operational budget of EUR 0 per year; 
for  JRC,  an  operational  budget  of  EUR  180  000  per  year  to  cover  integration  of  IPCHEM  in  the 
common data platform and handing over of IPCHEM operation to ECHA. 

After the initial phase of 3 years, the resource requirement is reduced to maintain the infrastructure and the 
underlying processes. This phase will require  

• 
• 
• 
• 
• 

for ECHA, 4 FTEs (4 TAs) per year and operational budget of EUR 600 000 per year; 
for EEA, 1 FTE (1 TA) per year and operational budget of EUR 200 000 per year; 
for EFSA, 2 FTEs (2 CAs) per year and operational budget of EUR 500 000 per year; 
for EU-OSHA, 0 FTEs per year and operational budget of EUR 0 per year; 
for EMA, 2 FTEs (2 CAs) per year and operational budget of EUR 0.  

Information Platform for Chemical Monitoring (IPCHEM) will be formally established and its operation 
will be reattributed to the Agencies. For this work,  

•  ECHA  will  need  as  of  the  second  year  2  FTEs  (1  TA  +  1  CA)  per  year  and  as  of  the  third  year 

operational budget of EUR 180 000 per year; 

26 

 
 
 
 
 
 
 
 
 
 
•  EEA will need as of the first year 1 FTE (1 TA) per year and the operational budget in the first year 
EUR 0, in the second year EUR 200 000, in the third year EUR 200 000 and as of the fourth year EUR 
50 000 per year.  

The operation of IPCHEM is currently done by the Commission and the resource use accounts for total of 4.5 
FTEs/year (DG JRC staff 2.5 FTEs/year + IT experts intramurous 2 FTEs/year (EUR  130 000/year)). The 
operation of IPCHEM will be entrusted to ECHA which will also integrate it into the Common Data Platform. 
As this work will be reattributed to ECHA, the resources at the Commission’s side will be saved. Hosting of 
data will be entrusted to the Agencies based on their mandates (ECHA will host occupational data) and EEA 
will  host  indoor  air  data  and  collect  and  host  human  biomonitoring  data.  EFSA  already  provides  data  to 
IPCHEM  and  contributes  to  its  operation  and  will  not  require  any  additional  resources  to  continue  in  this 
activity. EMA and EU-OSHA currently do not systematically collect or receive data relevant for IPCHEM and 
therefore will not require any additional resources.  

Database containing information on regulatory processes on chemicals will be established on the basis of 
existing (public) activities coordination tool ((P)ACT) and enlarging its scope to cover all relevant legislation 
with safety assessment processes and initiatives to promote coordination of safety assessment activities across 
EU legislation and provide transparency on the ongoing assessments. This work will impact ECHA, EEA, 
EFSA  and  EU-OSHA  but  will  not  require  additional  resources  for  the  agencies.  ECHA  already  operates 
(P)ACT for REACH, CLP and POPs processes. EFSA already operates OpenEFSA which has similar level of 
information as PACT for food and feed legislation. Resources for the operation and continuous provision of 
information are to be absorbed by the Agencies as part of the existing processes. EEA and EU-OSHA are 
currently not involved in any processes relevant for the database, therefore no resources are required for them. 
The development and coordination of the system is covered by the resources provided for the common data 
platform. 

Repository of reference values will be established to promote the reuse of existing reference values and thus 
improve coherence of assessments and reduce repetition of deriving reference values. The proposal will impact 
ECHA, EEA, EFSA, EMA, EU-OSHA and the Commission. To perform the required work, ECHA will need 
as of the first year 1 FTE (1 TA) per year and operational budget of EUR 0 in the first year, EUR 650 000 in 
the second year, EUR 650 000 in the third year and as of the fourth year EUR 200 000 per year. No additional 
resources will be needed for EEA, EFSA, EMA, EU-OSHA or the Commission. ECHA has developed and 
operates the EU Chemicals Legislation Finder (EUCLEF). EUCLEF lists some regulatory reference values 
derived and applicable under these legislative pieces. ECHA will have to collate the ‘old scientific reference 
values’  which  can  be  done  via  contracting.  The  new  scientific  reference  values  will  be  provided  to  the 
repository progressively as part of ECHA’s assessment processes. ECHA will require additional resources for 
developing, operating and maintain the repository, being in contact with data providers. EFSA has developed 
and  is  maintaining  the  OpenFoodTox  database  that  summarises  the  scientific  reference  values  derived  by 
EFSA as part of its assessment activities. EFSA will continue its activity and will provide the information to 
the new repository as part of its existing resources. Therefore, no additional resources are required. EMA will 
need to provide to the new repository on continuous basis all new predicted no effect concentrations (PNECs) 
derived for human and veterinary medicinal products after entry into force of this legislation. This can be done 
efficiently  as  part  of  EMA’s  future  assessment  activities.  In  addition,  this  can  be  automatized  for  human 
medicines  as  digitalisation  of  environmental  risk  assessment  is  foreseen  as  part  of  the  revision  of  human 
medicinal product legislation. Therefore, no additional resources are required. EEA and EU-OSHA currently 
do not hold any relevant data for the repository. Therefore, no additional resources are required.  

The establishment and operation of a database with information on applicable laws and legal obligations 
applicable to chemicals under Union legislation to promote compliance will be formalised. This work will 
impact  ECHA  but  will  not  require  additional  resources  under  this  proposal.  ECHA  already  operates  EU 
chemical legislative finder (EUCLEF) as part of the contribution agreement with DG GROW. The contribution 
agreement amounts to ca. EUR 1.0 – 1.4 million annually. ECHA runs the service through the employment of 
4 interim staff members (ca. EUR 270 000/year) and via contractors: communication activities and external 
helpdesk  ca.  EUR  60 000/year,  IT  costs  EUR  200 000/year,  data  costs  EUR  430 000/year.  These  existing 
resources  will  be  used  to  continue  operating,  further  developing  and  slightly  expanding  the  system.  The 

27 

 
 
resources for major extension of the system, such as the repository of reference values, are provided under the 
work on repository of reference values. Although no resources are required under this proposal, the legislative 
proposal  for  a  regulation  on  ECHA  should  address  the  fact  that  the  operation  of  the  EUCLEF  became  a 
structural task for ECHA and that the financing should become part of the annual contribution to ECHA. 

Database  on  environmental  sustainability  related  data  on  chemicals  will  be established.  The  work  will 
impact ECHA. ECHA will be required to set up the database, operate it, establish and maintain the flows of 
adequate data into the database and provide interpretation of data. Other agencies (EEA, EFSA, EMA and EU-
OSHA), if they host environmental sustainable data on chemicals, will provide that data to ECHA. To perform 
the work, ECHA will need as of the second year 1 FTE (1 TA) per year and operational budget of EUR 0 per 
year. Other agencies will not need additional resources as their task is small, currently do not hold any relevant 
data and the potential work can be absorbed by the agencies’ current resources.  

Data generation mechanism will be established to allow ECHA and the Commission to commission studies 
supporting the implementation of Union chemicals legislation within ECHA’s mandate or contributing to the 
development  of  Union  chemicals  policy.  The  studies  can  be  commissioned  only  when  results  cannot  be 
obtained  through  existing  legal  provisions  and  they  shall  not  have  predominant  research  and  development 
objective. The mechanism will allow ECHA and the Commission to generate data where needed and cannot 
be obtained otherwise. ECHA’s involvement is necessary as commissioning of such studies requires technical 
expertise. To perform the work, ECHA will require in the first year 1 FTE (1 TA) and operational budget of 
EUR 0, in the second year 2 FTEs (1 TA and 1 CA) and operational budget of EUR 1 000 000, in the third 
year 2 FTEs (1 TA and 1 CA) and operational budget of EUR 3 000 000 and as of the fourth year 2 FTEs (1 
TA and 1 CA) per year and operational budget of EUR 5 000 000 per year. No current process exists, but there 
is a complementary process operated by EFSA for the food sector (4 FTEs/year, EUR 15 000 000/year). This 
will continue to be operated next to the new one and the two Agencies (ECHA and EFSA) are required to 
cooperate when commissioning such studies and develop a joint plan.  

The obligation to notify studies before they start will be expanded from food sector to all chemical sector. 
The work will require additional resource for ECHA. ECHA will need as of the first year 3 FTEs (1 TA and 2 
CAs) per year and operational budget in the first year of EUR 0, in the second year EUR 1 200 000, in the 
third year EUR 400 000 and as of the fourth year EUR 200 000 per year. ECHA will be required to develop 
the database, operate it, facilitate and check compliance with the provisions and provide feedback to the duty 
holders. EFSA already operates a database of notification of studies to serve the obligation under the food 
sector legislation. The resource use amounts to 2 FTEs/year and EUR 400 000/year. EFSA and ECHA will be 
required to ensure compatibility of the systems. No additional resources are needed for this for EFSA.  

The  operation  of the indicators framework for  chemicals  will  be  formalised  and  an  early warning  and 
action system for chemicals will be established. The work will require additional resources for EEA. EEA 
will need as of the first year 1 FTE (1 TA) per year and operational budget for the first year of EUR 0, for the 
second year EUR 300 000 and as of the third year EUR 150 000 per year. EEA and ECHA already jointly 
develop the indicators framework for chemicals as part of the commitment under the 8th Environment Action 
Programme. As the resources for indicator framework (2 FTEs per year for ECHA, 1 FTE per year for EEA) 
were  already  attribution  as  part  of  the  8th  EAP,  no  additional  resources  are  needed  for  this  work.  The 
establishment of the early warning and action system is a new, non-existing task that aims to significantly 
shorten the regulatory response to identified risks. The EEA will be tasked to collect early warning signals 
from other agencies, Member State and by its own activity and compile annually a report for discussion and 
decision on the follow up with Member States authorities. Other contributing agencies (ECHA, EFSA, EMA 
and EU-OSHA) will absorb the costs as part of exiting activities. In case of ECHA, the resources attributed 
for  the  indicator  framework  will  be  partly  used  to  support  the  EEA  by  generating  relevant  early  warning 
signals. 

Observatory  for  specific  chemicals  with  potential  contribution  to  emerging  chemical  risks  will  be 
established. This will de facto formalise the operation of existing EU Observatory for nanomaterials and extend 
its scope to specific chemicals considered to benefit from additional scrutiny and reliable information on their 
properties,  safety  aspects,  uses  and  market  presence.  This  work  will  impact  ECHA  but  will  not  require 

28 

 
 
additional resources under this proposal. ECHA operates the EU Observatory for nanomaterials as part of a 
contribution agreement with DG GROW. The resource use amounts to approximately EUR 700 000 per year 
including the 3 FTEs (3 CA). These existing resources will be used to continue operating, further developing 
and slightly expanding the system. The legislative proposal in preparation for a regulation on ECHA should 
address the fact that the operation of the EUCLEF became a structural task for ECHA and that the financing 
should become part of the annual contribution to ECHA. 

Impact on committees of Agencies 

There is no or a low impact of this proposal on committees of ECHA, EFSA and EMA and on the network of 
EEA. The rapporteurs of ECHA, EFSA and EMA committees that derive reference values will have to record 
the  reference  values  and  associated  metadata  into  the  repository  of  reference  values  or  structure  this 
information in the opinion to enable automatic extraction of that information to the repository. In addition, 
ECHA committees might be required to provide their suggestions for testing and monitoring of substances. 
The network of EEA will be required to assist in the collection of human biomonitoring data and early warning 
signals from member countries activities. There is no impact of this proposal on advisory groups of EU-OSHA.  

10.  OVERALL IMPACTS FROM ALL (RE-)ATTRIBUTIONS  

10.1  Added value and synergies of the (re-)attributions  

Added value 

The consolidation of scientific and technical work in the EU agencies provides for several benefits:  

1.  Scientific  consistency  and  coherence  -  Less  actors  involved  in  the  scientific  and  technical  work, 
centralising the work in the Agencies and requiring the Agencies to cooperate and solve possible divergent 
opinions leads to improved coherence and scientific consistency among the legislative pieces and among 
the assessments. The consolidation of work allows to better align priority setting, timelines, processes and 
methodologies used for the assessments. It facilitates reuse of assessment insights developed under one 
piece of chemical legislation in the assessment under another piece of legislation. It also facilitates the 
reuse of data collected under one piece of chemical legislation in the assessment under another piece of 
legislation.  It  contributes  to  alignment  of  data  formats,  IT  solutions,  data  storing  practices  and  thus 
contribute to improved interoperability of data.  

2.  Robustness of assessment and acceptance - Involvement of the EU agencies and their committees in the 
scientific and technical work on chemicals adds more scientific expertise, ensures high quality of scientific 
advice and leads to improved robustness of assessments and thus their acceptance. Centralising data on 
chemicals  in  the  EU  Agencies  will  increase  the  knowledgebase  and  improve  the  robustness  of  the 
scientific advice provided. Re-use of (same) data will further facilitate acceptance of conclusions.  

3.  Independence - Moving scientific and technical work on chemicals from Commission services, ad hoc 
committees or consultants to EU agencies and their committees reinforces the separation between science 
and  policy  or  between  risk  assessment  and  management.  Agencies  and  their  committees  work  under 
stricter conflict of interest avoidance rules, improving guarantees of independent scientific advice to the 
Commission. 

4.  Transparency - Involvement of the EU agencies in scientific and technical work will ensure transparency 

to the process in terms of  

-  overall process transparency; 
-  publication  of  regulatory  intentions  of  EU  authorities  and  application  submission  intentions 

improves predictability for all stakeholders; 

-  public consultation/call for evidence; 
-  stakeholder involvement/observer status; 
-  dissemination of scientific data and outcomes. 

The increased transparency will further increase the acceptance of the outcomes and trust in the regulatory 
system.  

29 

 
 
Synergies 

The  EU  agencies  already  perform  similar  work  to  the  work  that  is  to  be  (re-)attributed  to  them.  The 
consolidation of scientific and technical work in the EU agencies therefore provides for number of synergies: 

1.  Reuse of capabilities - The existing agencies’ capabilities, such as hazard, risk and exposure assessment, 
development of committee opinions, development of methodologies, IT capabilities for submission of 
information by industry and Member States, collection and processing of data, stakeholder consultations, 
dissemination, can be reused in performing the (re-)attributed tasks. 

2.  Reuse of data, information  and knowledge  -  The information collected  by  the  agencies  on substances 
under  one  piece  of  legislation  can  be  reused  under  other  pieces  of  legislation.  The  knowledge  on  a 
substance developed under one piece of legislation can be reused under other legislation.  

3.  Workload  balancing  -  More  similar  work  consolidated  at  one  place  allows  for  better  balancing  the 

workload across the year and thus better using existing capacities at the Agencies.  

4.  IT tools: automation and economies of scale - Existing IT tools of the Agencies after some adaptation of 
the  tools  or  the  processes  can  be  reused  to  support  the  tasks  to  be  reattributed  to  the  Agencies.  This 
includes data submission and reporting tools, tools for case management, public consultation, interaction 
with Member States, regulatory intentions management and data dissemination 

5.  Support services: economies of scale - Existing scientific support services (such as committee secretariat, 
prioritisation and grouping of substances, substance identification, data management and dissemination) 
and administrative services of the agencies can be reused to support the tasks to be (re-)attributed to the 
agencies.  

10.2  Overall impact on resources  

Overall impact on resources per legislation and per agency 

The  (re-)attribution  of  scientific  and technical  work  on  chemicals  to the  EU  Agencies  with  accompanying 
resources has been already proposed under 8 legislative proposals and one research cooperation action. The 
accompanying  resources  already  attributed  to  the  EU  agencies  following  legislative  initiatives  already 
proposed by the Commission and some of which are already adopted by the co-legislator vary per year (see 
Table 8), with 54 FTEs (42 TA + 12 CA) and EUR 2 260 000 in 2024, 76 FTEs (63 TA + 13 CA) and EUR 
1 873 000 in 2025, 92 FTEs (79 TA + 13 CA) and EUR 1 726 000 in 2026 and 98 FTEs (88 TA + 10 CA) 
and  EUR  1  463  000 in  2027.  The majority  of  resources  were allocated  to  EMA  (42  –  60  FTEs per  year), 
followed by ECHA (24 – 29 FTEs and EUR 1 257 000 – EUR 1 364 000 per year) and EEA (9 – 11 FTEs and 
EUR 180 000 – EUR 919 000 per year). The majority of resources proposed for EMA are not related to the 
scope of the one substance, one assessment, but to improvement of processes for authorisation of medicinal 
products for human use.  

Table 8. Resource already allocated or proposed (operational costs in EUR 1 000) 

Activity  

2024 

2025 

2026 

2027 

2024 

2025 

2026  2027 

FTEs 

Operational costs 

TA  CA  TA  CA  TA  CA  TA  CA 

Already adopted by the co-legislators 
Drinking water directive 

Regulation  on  serious  cross-border  threats  to 
health  
European  Partnership  for  the  Assessment  of 
Risks from Chemicals  
Commission 
2022/1979 under SEVESO directive 
Batteries regulation  

implementing 

decision 

3 

0 

0 

3 

2 

2 

0 

4 

1 

1 

6 

0 

0 

3 

2 

3 

0 

4 

1 

1 

7 

0 

0 

3 

2 

3 

0 

4 

1 

1 

8 

0 

0 

3 

2 

3 

510 

520 

530 

540 

0 

0 

0 

2 

1 

0 

289 

289 

289 

330 

70 

158 

158 

70 

25 

0 

0 

70 

25 

Already proposed by the Commission (with resources) 
0 
E-PRTR regulation  

2 

2 

0 

2 

0 

2 

0 

170 

70 

30 

30 

30 

 
 
 
 
 
 
 
 
 
 
 
 
Industrial emissions directive 

Water legislation  

Legislation on medicinal products  for human 
use 
SUM 

3 

10 

19 

0 

4 

0 

3 

10 

37 

0 

4 

0 

3 

10 

52 

0 

4 

0 

3 

10 

60 

0 

4 

0 

0 

0 

0 

0 

803 

766 

782 

798 

0 

0 

0 

0 

42 

12 

63 

13 

79 

13 

88 

10 

2 260 

1 873 

1 726  1 463 

Table 9. Resources already allocated or proposed (operational costs in EUR 1 000) 

Agency 

ECHA 
EEA 
EMA 
SUM 

2024 

2025 

2026 

2027 

2024 

FTEs 

Operational costs 
2026 

2025 

TA  CA  TA  CA  TA 
19 
18 
15 
8 
8 
8 
52 
37 
19 
79 
63 
42 

9 
3 
0 
12 

10 
3 
0 
13 

CA  TA  CA 
9 
20 
1 
8 
0 
60 
10 
88 

10 
3 
0 
13 

1 341 
919 
0 
2 260 

1 364 
509 
0 
1 873 

1 257 
469 
0 
1 726 

2027 

1 283 
180 
0 
1 463 

The (re-)attribution of scientific and technical work has been already proposed by the Commission also under 
the revision of CLP regulation, packaging and packaging waste directive, end-of-life vehicle directive and toys 
safety  directive  but  without  the  allocation  of  resources.  As  the  resource  allocation  is  still  pending,  these 
initiatives are mentioned in the table with pending resource needs below.  

The re-attribution of tasks to the EU agencies is still to be proposed under 5 upcoming legislative proposals 
and under the reattribution of non-chemical assessment work from SCHEER to SAM within the Commission. 
After  considering  all  possible  synergies  from  the  reattributions,  the  pending  resource  needs  for  the  work 
attributed to the EU Agencies without the resources and for the work to be attributed varies between 56 – 69 
FTEs (34-38 TA + 19-31 CAs) per year and operational budget of EUR 1 051 000 – EUR 10 300 000 per 
year. The details are provided in Table 10. The majority of the resources is to be allocated to ECHA (46 – 55 
FTEs and EUR 101 000 – EUR 8 666 000 per year), followed by EEA (3 – 5 FTEs and EUR 400 000 – EUR 
766 000 per year), EFSA (2 – 5 FTEs and EUR 500 000 – EUR 670 000 per year), EMA (2 – 3 FTEs and EUR 
0 – EUR 100 000 per year) and SAM (1 FTE per year). The details of allocations per agency are provided in 
Table 11.  

Table 10. Pending resource needs per legislative proposal (operational costs in EUR 1 000) 

FTEs 

Operational costs 

Activity  

2025 

2026 

2027 

2028 

2025  2026  2027  2028 

TA  CA  TA  CA  TA  CA  TA  CA 

Already proposed by the Commission (but without resources) 

CLP regulation   

Directive on packaging and packaging waste  

Directive on end-of life-vehicles  

Toy safety directive 

3 

1 

1 

2 

2 

0 

0 

0 

3 

1 

1 

2 

2 

0 

0 

0 

3 

1 

1 

2 

2 

0 

0 

0 

Proposed by the Commission as part of the package on one substance, one assessment 

Directive on reattribution 

   RoHS directive  

Regulation on reattribution 

   POPs regulation 

   Medical devices regulation 

   EEA founding regulation 

   General Food Law 

Regulation on chemicals data 

   Common data platform  

3 

3 

1 

1 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

4 

4 

2 

2 

0 

0 

0 

3 

3 

0 

0 

0 

0 

0 

4 

4 

2 

2 

0 

0 

0 

3 

3 

0 

0 

0 

0 

0 

10 

5 

18 

16 

12 

5 

20 

16 

12 

5 

20 

16 

12 

5 

3 

0 

1 

2 

4 

4 

2 

2 

0 

0 

0 

2 

0 

0 

0 

3 

3 

0 

0 

0 

0 

0 

8 

4 

0 

0 

0 

0 

66 

66 

35 

35 

0 

0 

0 

0 

0 

0 

0 

33 

33 

50 

50 

0 

0 

0 

0 

0 

0 

0 

33 

33 

50 

50 

0 

0 

0 

0 

0 

0 

0 

33 

33 

50 

50 

0 

0 

0 

950  6 792  8 657  7 080 

950  3 442  4 077  1 300 

31 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   Information Platform for Chemical Monitoring 

   Information on regulatory processes on chemicals  

   Repository of reference values  

Information on the obligations under Union acts 
on chemicals  
Environmental sustainability related data on 
chemicals 

   Data generation mechanism  

Mechanism for notification of studies & database 
for study notifications 
Early warning and action system for emerging 
chemical risks and framework of indicators 
Observatory for specific chemicals with potential 
contribution to emerging chemical risks 

Planned to be proposed by the Commission  

Proposal for regulation on ECHA  

   Cooperation of ECHA with other agencies 

   Scientific opinions on OELs 

Information  on  the  obligations  under  Union  acts 
on chemicals  
Observatory for specific chemicals with potential 
contribution to emerging chemical risks 

REACH regulation 

Cosmetic products regulation 

Scientific  advice  of  SCHEER  on  non-chemical 
topics  
SUM 

1 

0 

1 

0 

0 

1 

1 

1 

0 

5 

0 

3 

2 

0 

0 

7 

1 

0 

0 

0 

0 

0 

0 

2 

0 

0 

6 

0 

2 

1 

3 

0 

0 

0 

2 

0 

1 

0 

1 

1 

1 

1 

0 

5 

0 

3 

2 

0 

0 

7 

1 

1 

0 

0 

0 

0 

1 

2 

0 

0 

6 

0 

2 

1 

3 

0 

0 

0 

2 

0 

1 

0 

1 

1 

1 

1 

0 

5 

0 

3 

2 

0 

0 

7 

1 

1 

0 

0 

0 

0 

1 

2 

0 

0 

6 

0 

2 

1 

3 

0 

0 

0 

2 

0 

1 

0 

1 

1 

1 

1 

0 

5 

0 

3 

2 

0 

0 

7 

1 

1 

0 

0 

0 

0 

1 

2 

0 

0 

6 

0 

2 

1 

3 

0 

0 

0 

0 

0 

0 

0 

0 

200 

380 

230 

0 

0 

0 

650 

650 

200 

0 

0 

0 

0 

0 

0 

0  1 000  3 000  5 000 

0  1200 

400 

200 

0 

0 

300 

150 

150 

0 

0 

0 

0  1 260  1 260  1 260 

0 

0 

0 

0 

0 

0 

0 

0 

200 

630 

0 

200 

630 

0 

200 

630 

430 

430 

430 

0 

0 

0 

300 

300 

300 

0 

0 

0 

34 

26 

38 

31 

38 

31 

37 

19  1 051  8 435  10 300  8 723 

Table 11. Pending resource needs per agency (operational costs in EUR 1 000) 

Agency / Service 

ECHA 
EEA 
EFSA 
EMA 
EU-OSHA 
JRC 
SAM 
SUM 

FTEs 

2025 
TA  CA 
16 
2 
5 
3 
0 
0 
0 
26 

30 
3 
0 
0 
0 
0 
1 
34 

2026 

2027 

2028 

TA 
34 
3 
0 
0 
0 
0 
1 
38 

CA 
21 
2 
5 
3 
0 
0 
0 
31 

TA 
34 
3 
0 
0 
0 
0 
1 
38 

CA 
21 
2 
5 
3 
0 
0 
0 
31 

TA 
33 
3 
0 
0 
0 
0 
1 
37 

CA 
15 
0 
2 
2 
0 
0 
0 
19 

2025 

101 
0 
670 
100 
0 
180 
0 
1 051 

Operational costs 
2027 

2026 

6 719 
766 
670 
100 
0 
180 
0 
8 435 

8 666 
684 
670 
100 
0 
180 
0 
10 300 

2028 

7 823 
400 
500 
0 
0 
0 
0 
8 723 

Overall resources saved  

It must be noted that some activities that have been reattributed were performed also before the reattribution 
and resources were used for those activities (see Table 12 below). The resources used for rapid risk assessment 
for serious cross-border threats, the operation of databases under the SEVESO directive and implementation 
work on chemicals under surface and ground water legislation consisted of 3.6 FTEs/year of regular staff, 7 
FTEs per year of intramurous contractors or interim staff (ca. EUR 460 000 per year) and operational 
budget of EUR 127 000 per year. These resources will be saved at the institution that has performed the tasks 
so far. 

Table 12. Resource use for technical and scientific work before it was (re-)attributed to EU Agencies 

Regulation  on  serious  cross-border 
threats to health  

Total ca. 0.6 FTE/year + EUR 48 000/year: DG SANTE SCHEER secretariat 0.6 FTE (ca. 
20% of SCHEER secretariat work), EUR 48 000 /year for indemnities, travel, e.g. costs for 
members of the committee 

32 

 
 
 
 
 
 
 
 
 
 
Commission implementing decision 
(EU) 2022/1979 under the SEVESO 
Directive (2012/18/EU) 
Water legislation (surface and 
ground) 

SUM 

Total 4 FTEs: DG JRC 1 FTE (core staff) + 3 FTEs external contractors  

Total: ca. 6.0 FTEs and EUR 79 200/year:  
EQSD: DG JRC 1 FTE /year (core staff) + contracting out for EUR 232 030 per year (= 
3.5 FTEs), DG ENV contracting out for EUR 100 000 every 6 years for impact assessment 
(= ca. 0.25 FTEs/year). In addition, 1/3rd of the SCHEER Committee capacity is dedicated 
to water legislation (17 committee members + external experts); DG SANTE = 1 FTE 
(core staff) and EUR 79 200 EUR per year (30% of 3 FTEs - the secretariat to SCHEER. 
GWD: DG ENV contracting out EUR 10 560/year to get support to voluntary watchlist 
(=0.16 FTEs) 
3.6 FTEs / year of regular staff; 7 FTEs / year of intramurous contractors or interim 
staff (ca. EUR 460 000/ year); Operational costs of ca. EUR 127 000 per year 

Some tasks that are still to be (re-)attributed via the upcoming proposals are being currently performed and the 
resources are allocated to them (see Table 13 below). The resources currently used for the RoHS directive, 
POPs  regulation,  medical  devices  regulation,  operation  of  IPCHEM,  EUCLEF  and  observatory  for 
nanomaterials,  for  scientific  opinions  on  OELs,  end-of-life  vehicle  directive,  cosmetics  regulation  and  toy 
safety directive amount to 12.8 FTEs per year of regular staff, 10.9 FTEs of intramurous contractors or interim 
staff (705 K€ per year) and an operational budget of EUR 2 023 000 – EUR 2 423 000 /year. As these tasks 
will be reattributed or formalised, the current resources used for these tasks will not be needed and will be 
saved  at  the  institution  that  performs  or  finances  the  tasks  today.  Therefore,  the  total  net  increase  in  the 
resources is lower than indicated in the Table 10, and for the tasks to be still reattributed accounts for 
32 – 45 FTEs per year and an operational budget of up to EUR 8 277 000 per year. 

Table 13. Current resource use for technical and scientific work that is to be (re-)attributed to EU Agencies 

RoHS directive 

POPs regulation  

Total ca. 2.74 FTEs/year: EUR 145 000 annually (on average) for outsourcing the review of 
exemptions (= ca. 2.2 FTEs/year) + a contract of EUR 180 000 on average each 5 years for 
reviewing restrictions (= 0.54 FTE/year). (In addition, DG ENV ca. 1.5 FTE/year (for overall 
RoHS implementation) whose work will remain) 

Total ca. 1.5 FTEs/year: EUR 300 000 for consultants every 3 years (=1.5 FTE/year). (In 
addition, DG ENV ca. 0.5 FTE/year (implementing the review of Annexes IV and V) whose 
work will remain) 

IPCHEM 

regulatory 

Medical devices regulation  

Information  on 
processes on chemicals  

Information on the 
obligations under Union acts 
on chemicals  

Total ca. 0.3 FTE/year + EUR 24 000/year: DG SANTE SCHEER secretariat 0.3 FTE (ca. 10% 
of SCHEER secretariat work), EUR 24 000/year for indemnities, travel, e.g. costs for members 
of the committee. (In addition, DG SANTE (policy unit) 0.1 FTE/year whose work will remain). 
Total 4.5 FTEs/year: DG JRC staff 2.5 FTEs/year + IT experts intramurous 2 FTEs/year (EUR 
130 000 per year) 
ECHA already operates (P)ACT for REACH, CLP and POPs processes. EFSA already operates 
OpenEFSA which has similar level of information as PACT. Resources for the operation and 
continuous provision of information are to be absorbed by the Agencies. 
ECHA already operates EUCLEF and this is financed through the contribution agreement 
between DG GROW and ECHA: Total ca. EUR 1.0 – 1.4 million annually, with no posts.  
ECHA runs the service through the employment of 4 interim staff members (ca. EUR 270 
000/year) and via contractors: communication activities and external helpdesk ca. EUR 60 
000/year, IT costs EUR 200 000/year, data costs EUR 430 000/year.  
ECHA already operates the EU Observatory on Nanomaterials and this is financed via a 
contribution agreement between DG GROW and ECHA: Total of ca. EUR 700 000 per year 
including the 3 posts per year: 3 CAs/year (ca. EUR 270 000/year) and operational costs of ca. 
EUR 430 000/year.  
Total 4 FTEs/year and operational budget of ca. EUR 575 000/year: DG EMPL Service Level 
Agreement with ECHA for assessment of 5 substances annually – in total EUR 975 000 that 
includes 4 CA posts.  
Total ca. 0.36 FTE/year for assessment of exemptions: a contract of EUR 60 000 every 2.5 years 
for reviewing exemptions (= ca. 0.36 FTE annually). (In addition, DGENV ca. 0.1 FTE dedicated 
to the work on hazardous substances whose work will remain). 
Cosmetic products regulation   Total ca. 3 FTEs/year + full SCCS membership + EUR 240 000/year: DG SANTE 3 FTEs for the 

Observatory for specific 
chemicals with potential 
contribution to emerging 
chemical risks 
Scientific opinions on OELs 

End-of-life vehicle directive 

Toy safety directive 

secretariat of SCCS + 14 members of SCCS and 4 external experts + ca. EUR 240 000 /year for 
reimbursement of members (at peak up to EUR 340 000/year). (In addition, DG GROW ca. 1 
FTE for overall implementation of the related provisions whose work will remain) 
Total ca. 0.3 FTEs/year + EUR 24 000/year: DG SANTE for SCHEER secretariat ca. 0.3 FTE 
(ca. 10% of SCHEER secretariat work) + EUR 24 000/year for reimbursements of SCHEER 

33 

 
 
 
 
 
SUM 

members (10% of SCHEER work). (In addition, DG GROW ca. 1 FTE/year for overall 
implementation of the related provisions) whose work will remain). 
12.8 FTEs/year regular staff; 10.9 FTEs/year interim staff + contracted staff; Operational 
budget: EUR 2 023 000 – 2 423 000 per year 

10.3  Overall impacts on ECHA 

Impact on ECHA’s resources 

The proposals made by the Commission so far have already proposed to strengthen ECHA in the long term by 
29 FTEs (see Table 14). An additional 48 FTEs are necessary in the long term to deal with the envisaged tasks 
that were already proposed by the Commission but without allocation of resources or are still to be proposed 
(see Table 15). Although the required reinforcement of ECHA seems significant, the allocation of 11 FTEs out 
of 48 will be de facto a regularisation of resources that already exist in ECHA via administrative agreements 
(4 FTEs for worker protection legislation and 3 FTEs for operation of EUON) or via a service level agreement 
(4 interim employees for operation of EUCLEF). In addition, the allocation of some additional 11 FTEs is a 
reattribution from other sources, mainly from contracting out the support (2.7 FTEs for RoHS directive, 1.5 
FTEs  for  POPs  regulation,  0.3  FTEs  for  medical  devices,  3.5  FTEs  for  IPCHEM,  3  FTEs  for  cosmetics 
regulation, 0.3 FTEs for toy safety directive and 0.36 FTEs for end-of-life vehicle directive). 

Table 14. Resource already allocated to or proposed to be allocated to ECHA (operational costs in EUR 1 000) 

Activity  

2024 

2025 

2026 

2027 

FTEs 

Operational costs 
2024  2025  2026  2027 

Drinking water directive    
Regulation on serious cross-border threats to health 
European Partnership for the Assessment of Risks 
from Chemicals 
Batteries regulation  
Industrial emissions directive 
Water legislation  
SUM 

TA  CA  TA  CA  TA  CA  TA  CA 
3 
0 
2 

8 
0 
0 

3 
0 
0 

2 
0 
2 

6 
0 
0 

3 
0 
2 

7 
0 
0 

3 
0 
2 

510 
0 
0 

520 
0 
0 

530 
0 
0 

540 
0 
0 

2 
3 
7 
15 

1 
0 
4 
9 

2 
3 
7 
18 

1 
0 
4 
10 

2 
3 
7 
19 

1 
0 
4 
10 

2 
3 
7 
20 

158 
0 
673 

0 
25 
0 
0 
718 
4 
9  1 341  1 364  1 257  1 283 

158 
0 
686 

25 
0 
702 

Table 15. ECHA pending resource needs per legislative proposal (operational costs in EUR 1 000) 

Activity  

FTEs 

2025 

2026 

2027 

2028 

TA  CA  TA  CA  TA  CA  TA  CA 

Operational costs 
2025  2026  2027  2028 

Already proposed by the Commission (but without resources) 
CLP Regulation   
Directive on packaging and packaging waste  
Directive on end-of life-vehicles  
Toys safety directive 
Proposed by the Commission as part of the package on one substance, one assessment 

3 
1 
1 
2 

2 
0 
0 
0 

3 
1 
1 
2 

2 
0 
0 
0 

3 
1 
1 
2 

2 
0 
0 
0 

Directive on reattribution of tasks 
   RoHS Directive  
Regulation on reattribution of tasks 
   POPs regulation 
   Medical devices regulation 
Regulation on chemicals data 
   Common data platform  
   Information Platform for Chemical Monitoring 
   Information on regulatory processes on chemicals 
   Repository of reference values  

Information on the obligations under Union acts 
on chemicals 
Environmental sustainability related data on 
chemicals 

   Data generation mechanism  

Mechanism for notification of studies & database 
for study notifications 

3 
3 
1 
1 
0 
7 
4 
0 
0 
1 
0 

0 

1 
1 

0 
0 
0 
0 
0 
8 
6 
0 
0 
0 
0 

0 

0 
2 

4 
4 
2 
2 
0 
9 
4 
1 
0 
1 
0 

1 

1 
1 

3 
3 
0 
0 
0 
10 
6 
1 
0 
0 
0 

0 

1 
2 

4 
4 
2 
2 
0 
9 
4 
1 
0 
1 
0 

1 

1 
1 

3 
3 
0 
0 
0 
10 
6 
1 
0 
0 
0 

0 

1 
2 

3 
0 
1 
2 

4 
4 
2 
2 
0 
9 
4 
1 
0 
1 
0 

1 

1 
1 

2 
0 
0 
0 

3 
3 
0 
0 
0 
4 
0 
1 
0 
0 
0 

0 

1 
2 

0 
0 
0 
0 

0 
0 
0 
0 

0 
0 
0 
0 

0 
0 
0 
0 

33 
33 
50 
50 
0 

33 
33 
50 
50 
0 

33 
66 
33 
66 
50 
35 
50 
35 
0 
0 
0  5 076  7 023  6 180 
600 
0  2 226  2 793 
180 
180 
0 
0 
0 
0 
0 
0 
200 
650 
650 
0 
0 
0 
0 
0 

0 

0 

0 

0 

0  1 000  3 000  5 000 
200 
0  1 200 

400 

34 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Early warning and action system for emerging 
chemical risks and framework of indicators 
Observatory for specific chemicals with potential 
contribution to emerging chemical risks 

Planned to be proposed by the Commission  

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

Proposal for regulation on ECHA 
   ECHA’s cooperation with other agencies 
   Scientific opinions on OELs 
   EUCLEF  
   EU Observatory for Nanomaterials 
REACH regulation 
Cosmetic products regulation 
SUM 

5 
0 
3 
2 
0 
0 
7 
30 

6 
0 
2 
1 
3 
0 
0 
16 

5 
0 
3 
2 
0 
0 
7 
34 

6 
0 
2 
1 
3 
0 
0 
21 

5 
0 
3 
2 
0 
0 
7 
34 

6 
0 
2 
1 
3 
0 
0 
21 

5 
0 
3 
2 
0 
0 
7 
33 

6 
0 
2 
1 
3 
0 
0 
15 

0  1 260  1 260  1 260 
0 
0 
200 
0 
630 
0 
430 
0 
0 
0 
300 
0 
101  6 719  8 666  7 823 

0 
200 
630 
430 
0 
300 

0 
200 
630 
430 
0 
300 

Impact on ECHA’s expertise 

As regards the expertise, ECHA has adequate expertise to address the majority of the new tasks. One exception 
is the extension of the scope of assessments for waste stage under the batteries regulation, RoHS directive, 
directive on end-of-life vehicles, packaging and packaging waste directive and POPs regulation, for which 
ECHA will need to build or recruit additional expertise. ECHA will also need to acquire a new expertise as 
regards water monitoring and derivation of water quality standards. ECHA will further need to build expertise 
on  the  assessment  of  chemicals  in  materials  coming  in  contract  with  drinking  water,  where  assessment  is 
similar to food contact materials managed by EFSA.  

Impact on ECHA’s committees 

The estimated number of opinions per year from (re-)attribution of tasks is provided in the table below. It is 
expected that RAC will have to deliver additional 80 opinions per year as compared to today, while SEAC 
additional  50  opinions  per  year.  The  increase  in  number  of  RAC  opinions  represents  72%  increases  as 
compared today. It should be noted that the biggest increase comes from drinking water directive (50 opinions) 
and from CLP regulation (13.5 opinions). The rest of legislations accounts for just 16.5 opinions. In order to 
cope  with  increased  workload,  the  RAC  will require some adaptation  aiming  on  increasing the  number  of 
committee members (currently  RAC  membership is  at  50%  capacity),  attractiveness  of rapporteurship  and 
flexibility  in  structuring  the  work  of  the  committee.  This  is  envisaged  to  be  tackled  under  the  legislative 
proposal for regulation on ECHA that is in preparation. The increase in number of SEAC opinion is moderate. 
The SEAC in its current set up should be able to absorb the additional tasks, after some adaptations in similar 
direction as for the RAC.  

As regards the expertise, RAC has adequate expertise to address the majority of new tasks. The only exception 
is  the  extension  of  scope  of  assessments  for  waste  stage  under  the  batteries  regulation,  RoHS  directive, 
directive on end-of-life vehicles and packaging and packaging waste directive, for which RAC will need to 
build or recruit additional expertise. The SEAC expertise might need to be extended to cover the waste stage 
of products and chemicals as well.  

Table 16. Expected number of opinions from ECHA’s committees per year 

Legislation / process 
Drinking water directive 

-  Positive lists of substances 

Batteries regulation  

-  Restriction 
Water legislation 

-  Annex I Ground Water Directive 
-  Annex II Ground Water Directive  
-  Annex I EQS Directive 
-  Annex II EQS Directive  

CLP Regulation 

-  COM request for new hazard classes  

RoHS directive 
-  Restriction  
-  Request for exemption  

RAC 

50 

1 

1 
1 
4 
1 

13.5 

1 
3 

SEAC 

SCCS 

- 

1 

1 
1 
4 
1 

- 

1 
30 

- 

- 

- 
- 
- 
- 

- 

- 
- 

35 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
POPs regulation  

-  Review of Annexes IV and V  

Directive on end-of-life vehicle  

-  Review of existing exemptions 

Cosmetic products regulation  
-  Opinions on substances 
-  Notes of guidance 

Toy safety directive 
-  Assessments 

SUM 

10.4  Overall impacts on EEA 

Impact on EEA’s resources 

- 

- 

- 
- 

4.2 
79.7 

2 

5 

- 
- 

4.2 
50.2 

- 

- 

11 
1 

- 
12 

The proposals made by the Commission so far have already proposed to reinforce EEA in the long term by 11 
FTEs (see Table 17).  An additional 3 FTEs are necessary in the long term, topped up with 2 FTEs for short 
term, to deal with the new envisaged tasks under the Regulation on chemicals data (see Table 18). The first 
three years there will be a need of 5 FTEs (3 TA + 2 CA) and operational budget of up to EUR 766 000. In 
the fourth year and beyond, there will be a need of 3 FTEs (3 TA) per year and an operational budget of EUR 
400 000 per year. It should be noted that the allocation of 1 FTE out of those required by EEA is a reattribution 
of the existing resources used for operation of IPCHEM.  

Table 17. Resource already allocated or proposed to EEA per legislative proposal (operational costs in EUR 1 000) 

Activity  

FTEs 

2024 

2025 

2026 

2027 

Operational costs 
2024  2025  2026  2027 

Regulation on serious cross-border threat to health 
European  Partnership  for  the  Assessment  of  Risks 
from Chemicals 
Commission implementing decision 2022/1979 
under SEVESO directive 
E-PRTR regulation  
Water legislation (chemicals related tasks) 
SUM 

TA  CA  TA  CA  TA  CA  TA  CA 
0 
0 

0 
0 

0 
0 

0 
2 

0 
0 

0 
2 

0 
0 

0 
2 

0 
289 

0 
289 

0 
289 

0 
0 

3 

2 
3 
8 

1 

0 
0 
3 

3 

2 
3 
8 

1 

0 
0 
3 

3 

2 
3 
8 

1 

0 
0 
3 

3 

2 
3 
8 

1 

0 
0 
1 

330 

70 

70 

70 

170 
130 
919 

70 
80 
509 

30 
80 
469 

30 
80 
180 

Table 18. EEA pending resource needs per legislative proposal (operational costs in EUR 1 000) 

Activity  

2025 

2026 

2027 

2028 

FTEs 

Operational costs 
2025  2026  2027  2028 

Regulation on reattribution of tasks 
   POPs regulation 
   EEA founding regulation 
Regulation on chemicals data 
   Common data platform 
   Information Platform for Chemical Monitoring 
   Information on regulatory processes on chemicals 
   Repository of reference values 

Environmental sustainability related data on 
chemicals 
Early warning and action system for emerging 
chemical risks and framework of indicators 

SUM 

TA  CA  TA  CA  TA  CA  TA  CA 
0 
0 
0 
0 
0 
0 
0 
0 
0 

0 
0 
0 
3 
1 
1 
0 
0 
0 

0 
0 
0 
2 
2 
0 
0 
0 
0 

0 
0 
0 
3 
1 
1 
0 
0 
0 

0 
0 
0 
2 
2 
0 
0 
0 
0 

0 
0 
0 
3 
1 
1 
0 
0 
0 

0 
0 
0 
2 
2 
0 
0 
0 
0 

0 
0 
0 
3 
1 
1 
0 
0 
0 

1 

3 

0 

2 

1 

3 

0 

2 

1 

3 

0 

2 

1 

3 

0 

0 

0 
0 
0 
0 
0 
0 
0 
0 
0 

0 

0 

0 
0 
0 
766 
266 
200 
0 
0 
0 

0 
0 
0 
684 
334 
200 
0 
0 
0 

0 
0 
0 
400 
200 
50 
0 
0 
0 

300 

150 

150 

766 

684 

400 

The proposal for amendment of the POPs regulation via the regulation on (re-)attribution of tasks proposes to 
reattribute  the  existing  task  performed  by  the  Commission  to  EEA.  EEA  is  expected  to  host  the  chemical 
monitoring data in the environment of the POPs listed in Annex III, Part I and reported to ECHA under the 
POPs regulation. It is expected that this data stream will be very small or even zero. Member States are required 
to  report  those  monitoring  data  only  if  they  did  not  provide  it  to  EEA  under  other  reporting  obligation. 
However,  such  data  in  air  are  already  reported  to  EEA  and  the  proposal  for  revision  of  water  legislation 

36 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
proposed that such data in water will be reported to EEA as well.  As the potential hosting of data will be close 
to zero, this work, if any, can be absorbed by EEA’s existing resources.  

The proposal for amendment of the EEA founding regulation via the regulation on (re-)attribution of tasks 
proposes to better specify existing tasks of EEA. EEA is given a mandate to develop assessment methodologies 
related to chemicals within the mission of the agency and EEA is required to actively cooperate with other EU 
Agencies as regards exchange of data and development of methodologies. There are no resource implications 
as part of this work as the provisions formalise the activities performed, they prescribe the procedural steps to 
follow  and  they  enable  the  implementation  of  the  legislative  proposal  on  exchange  of  data.  Any  possible 
resource  needs  stemming  from  these  provisions  can  be  absorbed  by  the  existing  resources  of  EEA  or  the 
resources allocated for the common data platform. 

The proposal for a regulation on chemicals data proposes to reattribute some of the existing tasks related to 
IPCHEM from the Commission to EEA and to expand it. Under this task, the EEA will be requested to collect 
and host human biomonitoring data and host all environmental occurrence data and indoor air quality data 
currently held in IPCHEM. Additional resources are needed for these tasks. 

The  proposal  for  the  regulation  on  chemicals  data  will  further  attribute  a  new  task  to  EEA  related  to  the 
common data platform. EEA will be required to make the data it holds on chemicals available on a continuous 
basis to the common data platform in appropriate formats. Moreover, it will be required to set formats and 
controlled  vocabularies  in  its  area  of  competence  so  data  can  be  easily  shared,  and  it  will  be  required  to 
cooperate with ECHA and other agencies in developing and operating the common data platform. Additional 
resources are needed for these tasks. 

The proposal will also attribute to EEA a new task on the early warning and action system and formalise the 
existing task on the indicator framework which is already carried out by EEA. EEA will be required to compile 
and  collect  annually  the  early  warning  signals  into  a  report  to  be  presented  to  the  Commission,  relevant 
agencies and Member State authorities to consider whether any regulatory action is needed. EEA together with 
ECHA will be required to continue operating and populating the indicator framework for chemicals policy. 
Additional resources are needed for these tasks. 

Finally, the proposal will require EEA to provide available data into the database on information on regulatory 
processes on chemicals, the repository of reference values and the database on environmental sustainability 
related data on chemicals and to cooperate with ECHA on the development of the databases and the repository. 
No additional resources are needed for these tasks. EEA currently does not hold any relevant data for those 
databases  and  the  repository  and  the  small  contribution  to  the  development  of  the  tools  is  covered  by  the 
resources for the common data platform.  

Impact on EEA’s expertise 

As regards expertise, EEA has the necessary expertise, experience and the network to perform the allocated 
tasks.  

Impact on EEA’s network 

No significant impact on EEA’s network. The network might however be required to assist in the collection 
of human biomonitoring data and early warning signals from activities of EEA member countries. 

10.5  Overall impacts on EFSA 

Impact on EFSA’s resources 

The proposals made by the Commission so far have not proposed additional resources for EFSA (see Table 
19). EFSA was significantly reinforced in 2019 (by some 106 FTEs per year and operational budget of EUR 
17 800 000 per year) as part of the Regulation (EU) 2019/1381 on the transparency and sustainability of the 

37 

 
 
 
EU risk assessment in the food chain46 and the tasks attributed were small, thus could be covered by the existing 
EFSA’s resources. Additional 2 FTEs are necessary in the long term, topped up with 3 FTEs for short term, 
to deal with the envisaged tasks for EFSA under the proposal for regulation on chemicals  data (see Table 20). 
In total, the first three years there will be a need of 5 FTEs (5 CA) per year and operational budget of up to 
EUR 670 000 per year. In the fourth year and beyond, there will be a need of  2 FTE (1 CA) per year and 
operational budget of EUR 500 000 per year. 

Table 19. Resource already allocated or proposed to EFSA per legislative proposal (operational costs in EUR 1 000) 

Activity  

201FTEs 

2024 

2025 

2026 

2027 

Operational costs 
2024  2025  2026  2027 

Regulation on serious cross-border threat to health 
European  Partnership  for  the  Assessment  of  Risks 
from Chemicals 
SUM 

TA  CA  TA  CA  TA  CA  TA  CA 
0 
0 

0 
0 

0 
0 

0 
0 

0 
0 

0 
0 

0 
0 

0 
0 

0  

0 

0 

0 

0 

0 

0 

0 

0 
0 

0 

0 
0 

0 

0 
0 

0 

0 
0 

0 

Table 20. EFSA pending resource needs per legislative proposal (operational costs in EUR 1 000) 

Activity  

CLP Regulation  
Regulation on reattribution of tasks 
   General Food Law 
Regulation on chemicals data 
   Common data platform  
   Information Platform for Chemical Monitoring 

Information on regulatory processes on chemicals 

   Repository of reference values  

Environmental sustainability related data on 
chemicals 

   Data generation mechanism  
   Mechanism for notification of studies  

Early warning and action system and framework 
of indicators for chemicals 

SUM 

FTEs 

Operational costs 

2025 

2026 

2027 

2028  2025  2026  2027  2028 

TA  CA  TA  CA  TA  CA  TA  CA 
0 
0 
0 
2 
2 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 

0 
0 
0 
5 
5 
0 
0 
0 
0 

0 
0 
0 
5 
5 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 

0 
0 
0 
5 
5 
0 
0 
0 
0 

0 
0 
0 

0 

0 
0 
0 

5 

0 
0 
0 

0 

0 
0 
0 

5 

0 
0 
0 

0 

0 
0 
0 

5 

0 
0 
0 

0 

0 
0 
0 

2 

0 
0 
0 
670 
670 
0 
0 
0 
0 

0 
0  
0 

0 
0 
0 
670 
670 
0 
0 
0 
0 

0 
0 
0 

0 
0 
0 
670 
670 
0 
0 
0 
0 

0 
0 
0 

0 
0 
0 
500 
500 
0 
0 
0 
0 

0 
0 
0 

670  

670 

670 

500 

The proposal for revision of the CLP regulation proposes to attribute a new task to EFSA. EFSA on the request 
of the Commission is required to prepare a dossiers for harmonised classification of a substance. As hazard 
assessment is the core task of the Authority and the requests are unlikely to be too numerous, this work can be 
absorbed within the existing resources of the Authority.  

The proposal for amendment of the general food law via the regulation on (re-)attribution of tasks proposes to 
better specify the existing tasks of EFSA. EFSA will be required to actively cooperate with other EU Agencies 
as regards exchange of data and development of methodologies. EFSA will be further required to engage more 
in preventing or solving a divergent opinion with other EU Agencies. There are no resource implications of 
these amendments. The provisions formalise the activities performed, they prescribe the procedural steps to 
follow  and  they  enable  the  implementation  of  the  legislative  proposal  on  exchange  of  data.  Any  possible 
resource needs stemming from these provisions can be absorbed by the existing resources of EFSA. 

The proposal for a regulation on chemicals data proposes to formalise existing tasks and to attribute new tasks 
to EFSA.  

•  EFSA  will  be  required  to  make  data  on  chemicals  it  holds  available  on  a  continuous  basis  to  the 
common  data  platform  in  appropriate  formats.  In  addition,  it  will  be  required  to  set  formats  and 
controlled vocabularies in its area of competence so data can be easily shared, and it will be required 

46 Regulation (EU) of the European Parliament and of the Council of 20 June 2019 on the transparency and 
sustainability of the EU risk assessment in the food chain and amending Regulations (EC) No 178/2002, (EC) No 
1829/2003, (EC) No 2065/2003, (EC) No 1935/2004, (EC) No 1331/2008, (EC) No 1107/2009, (EU) 2015/2283) and 
Directive 2001/18/EC (OJ L 231 6.9.2019, p.1) 

38 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
to cooperate with ECHA and other agencies in developing and operating the common data platform. 
For  this,  EFSA  will  need  5  FTEs  during  3  years  to  launch  the  common  data  platform  with  all  its 
functionalities  and  data  and  then  2  FTEs  from  the  4th  year  and  onwards  to  ensure  adequate  input, 
operation and the further development of the common data platform and its underlying services.  
•  EFSA will also be required to contribute to the operation of and provide data to IPCHEM. This is an 

existing task of EFSA, so no additional resources are needed.  

•  EFSA  will  furthermore  be  required  to  provide  on  a  continuous  basis  information  on  the  status  of 
regulatory processes into the database with information on regulatory processes on chemicals.. EFSA 
already compiles such inform in the OpenEFSA database, which will be fed into the new database. 
There is no need for additional resources for this work as the compilation of information is ongoing 
and streamlining the information into the common data platform will be covered by the resources for 
the common data platform.  

•  EFSA will further be required to provide relevant information to the repository of reference values and 
contribute to its development. EFSA already compiles reference values in its OpenFoodTox database, 
which will be fed into the repository of reference values. There is no need for additional resources for 
this activity as it already exists and streamlining it to the repository of reference values will be covered 
by the resources for the common data platform.  

•  EFSA will be also required to provide available data into the database on environmental sustainability 
related data on chemicals. No additional resources are needed for this tasks, as EFSA currently does 
not hold any relevant data for this database and the potential small contribution to the development of 
the tools is covered by the resources for the common data platform. 

•  EFSA will be required to cooperate with ECHA on the commissioning of scientific studies. EFSA 
already commissions such studies under General Food Law and the additional resource needs for the 
cooperation with ECHA in doing so should be absorbed by EFSA within the existing allocation of 
resources.  

•  EFSA  will  be  required  to provide  input to  the indicators framework  and early warning  and  action 
system. There is no need for additional resources for this activity, because EFSA already operates the 
emerging risk exchange network (EREN) for the food sector and the output of that work will be fed 
into the early warning and action system on chemicals.  

•  Finally,  EFSA  will  be  required  to  ensure  the  compatibility  of  its  system  of  study  notifications 
established under Article 32b of the General Food Law with the database of study notifications to be 
set up by ECHA for remaining chemical legislation. The resources for this should be absorbed by the 
resources available in EFSA for the operation of its system of notification of studies.  

Impact on EFSA’s expertise 

As regard expertise, EFSA has the necessary expertise and experience to perform the allocated tasks. 

Impact on EFSA’s committees 

No significant impact on EFSA committees. The rapporteurs of EFSA committees that derive reference values 
might need to record the derived reference values and associated metadata into the repository of reference 
values or structure this information in the related opinion for automatic processing. 

10.6  Overall impacts on EMA 

Impact on EMA’s resources 

The proposals for legislation on medicinal products for human use proposed a significant strengthening of 
EMA to deal with the new tasks proposed to be entrusted to EMA (see Table 21), with some of the tasks being 
relevant for the proposals on reattribution of tasks and on chemicals data. However, additional 2 FTEs are 
necessary in the long term, topped up with 1 FTE for short term, to deal with the envisaged tasks for EMA 
under the proposal for regulation on chemicals  data (see Table 22). In total, the first three year there will be a 
need of 3 FTEs (3 CA) per year and an operational budget of EUR 100 000. In the fourth year and beyond, 
there will be a need of 2 FTEs (2 CA) per year and EUR 0 per year. 

39 

 
 
Table 21. Resources already allocated or proposed to EMA per legislative proposal (operational costs in EUR 1 000) 

Activity  

Serious cross-border threat regulation  
Legislation on medicinal products for human use 
SUM 

FTEs 

Operational costs 

2025 

2026 

2027 

2028  2025  2026  2027  2028 

TA  CA  TA  CA  TA  CA  TA  CA 
0 
0 
0 

0 
37 
37  

0 
60 
60 

0 
52 
52 

0 
60 
60 

0 
0 
0 

0 
0 
0 

0 
0 
0 

0 
0 
0 

0 
0 
0 

0 
0 
0 

0 
0 
0 

Table 22. EMA pending resource needs per legislative proposal (operational costs in EUR 1 000) 

Activity  

Regulation on chemicals data 
   Common data platform 
   Information Platform for Chemical Monitoring 
   Repository of reference values 

Environmental sustainability related data on 
chemicals  
Early warning and action system and framework 
of indicators 

SUM 

2025 

2026 

2027 

2028 

FTEs 

Operational costs 
2025  2026  2027  2028 

TA  CA  TA  CA  TA  CA  TA  CA 
2 
2 
0 
0 
0 

0 
0 
0 
0 
0 

3 
3 
0 
0 
0 

0 
0 
0 
0 
0 

3 
3 
0 
0 
0 

0 
0 
0 
0 
0 

3 
3 
0 
0 
0 

0 
0 
0 
0 
0 

0 

0 

0 

3 

0 

0 

0 

3 

0 

0 

0 

3 

0 

0 

0 

2 

100 
100 
0 
0 
0 

100 
100 
0 
0 
0 

100 
100 
0 
0 
0 

0 

0 

0 

100 

100 

100 

0 
0 
0 
0 
0 

0 

0 

The proposal for a regulation on chemicals data proposes new tasks for EMA.  

•  EMA will be required to make some of the  data it receives after entry into force of this regulation 
available on a continuous basis to ECHA for integration into the common data platform, it will be 
required to set formats and controlled vocabularies in its area of competence so data can be easily 
shared and it will be required to cooperate with ECHA and other agencies in developing and operating 
the common data platform. EMA will need additional resources for these tasks.  

•  EMA will be also required to provide occurrence data it holds to IPCHEM and provide cooperation to 
ECHA  in  integration  of  such  data  in  IPCHEM.  However,  EMA  currently  does  not  hold  any  data 
relevant to IPCHEM, therefore, no resources are required for this activity. Any cooperation required 
is covered by the resources for the common data platform.  

•  EMA will be required to cooperate with ECHA on the operation of the repository of reference values 
and  provide  on  a  continuous  basis  specific  reference  value  it  derives  (i.e.  predicted  no  effect 
concentration derived as part of the environmental risk assessment) to the repository. The cooperation 
with ECHA and provision of data is covered by the resources provided for the common data platform.  
•  EMA will be required to provide environmental sustainability related data on chemicals to ECHA and 
cooperate  with  ECHA  to  enable  integration  of  the  data  into  a  database.  EMA  however  does  not 
currently host any such data, therefore, no additional resources are required for this for EMA. Any 
cooperation with ECHA on setting up the database is covered by the resources for the common data 
platform. 

•  EMA will be required to provide available early warning signals from their areas of responsibility to 
EEA.  EMA  will require  no  additional  resources for  this  task,  as  the cooperation  is  covered  by the 
resources for the common data platform and potential provision of data is a small task that can be 
absorbed by EMA’s existing resources. 

•  Finally,  EMA  will  be  required  to  cooperate  with  EEA  and  other  agencies  on  the  establishment, 
operation and maintenance of the framework of indicators. EMA will require no additional resources 
for this task, as the cooperation is covered by the resources for the common data platform and potential 
provision of data is a small task that can be absorbed by EMA’s existing resources. 

Impact on EMA’s expertise 

As regards expertise, EMA has the necessary expertise and experience to perform the allocated tasks. 

Impact on EMA’s committees 

40 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
No significant impact on EMA committees. The rapporteurs of EMA committees that derive reference values 
might need to record the derived reference values and associated metadata into the repository of reference 
values or structure this information in the relevant opinion for automatic processing. 

10.7  Overall impacts on EU-OSHA 

Impact on EU-OSHA’s resources 

No additional resources are necessary for EU-OSHA to deal with the envisaged tasks under the proposal for 
regulation on chemicals data (see Table 23). 

Table 23. EU-OSHA pending resource needs per legislative proposal (operational costs in EUR 1 000) 

Activity  

FTEs 

2025 

2026 

2027 

2028 

Operational costs 
2025  2026  2027  2028 

Regulation on chemicals data 
   Common data platform 
   Information Platform for Chemical Monitoring 

Information on regulatory processes on chemicals 

   Repository of reference values 

Environmental sustainability related data on 
chemicals  
Early warning and action system and framework 
of indicators 

SUM 

TA  CA  TA  CA  TA  CA  TA  CA 
0 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 
0 
0 
0 
0 
0 

0 

0 

0 
0 
0 
0 
0 
0 

0 

0 

0 
0 
0 
0 
0 
0 

0 

0 

0 
0 
0 
0 
0 
0 

0 

0 

The  proposal  for  a  regulation  on  chemicals  data  requires  EU-OSHA  to  provide  data  to  ECHA  for  the 
integration  into  the  common  data  platform  and  to  cooperate  with  ECHA  in  developing  and  operating  the 
common data platform. It also requires EU-OSHA to provide relevant data to the information platform for 
chemical monitoring, database on regulatory processes on chemicals, repository of reference values, database 
of  environmental  sustainability  related  data  on  chemicals  and  to  early  warning  and  action  system  and 
framework  of  indicators.  EU-OSHA,  however,  does  not  currently  systematically  collect  or  host  any  data 
relevant  for  the  common  data  platform  and  its  building  blocks.  EU-OSHA’s  role  is  therefore  mainly  to 
contribute with their inputs and suggestions to the development of the common data platform and its building 
blocks. EU-OSHA can be seen as a ‘privileged’ user of the system who can provide input to the development 
and operation to ensure that the systems are developed in such way that they suit also the needs of EU-OSHA. 
No additional resources are needed for these tasks, as they can be covered by the existing resources.  

Impact on EU-OSHA’s expertise 

As regards expertise, EU-OSHA has the necessary expertise and experience to perform the allocated tasks. 

Impact on EU-OSHA’s committees 

There is no impact on EU-OSHA’s advisory groups or the management board.  

41 

 
 
 
 
 
 
 
 
 
 
 
 
ANNEX  I:  MISSION,  CORE  ACTIVITIES,  COMPETENCES  AND  SCIENTIFIC 
BODIES OF THE AGENCIES 

1.  EUROPEAN FOOD SAFETY AUTHORITY 

The European Food Safety Authority (EFSA) is an integral part of the EU’s food safety system. As outlined 
in its Founding Regulation (Regulation (EC) No 178/2002), the Authority’s mission is to contribute to the 
safety of the EU food and feed chain, mainly by: 

•  Providing  EU  risk  managers  with  independent,  up-to-date  and  fit-for-purpose  scientific  advice  on 
questions  related  to  food  and  feed  safety,  animal  health  and  welfare,  plant  health,  nutrition  and 
environmental issues specific to the above47 within the two main streams as described below: 

o  Generic risk assessments in the following areas of work: Plant health, Animal health, Animal 
welfare,  Chemicals  Hazards,  Biological  hazards,  Zoonoses-TSE-Antimicrobial  resistance 
monitoring and Nutrition 

o  Regulated  products  in  the  following  areas  of  work:  Novel  foods,  Feed  additives,  Food 

ingredients, Food contact materials, Genetically modified food/feed and Pesticides; 

•  Providing  EU  risk  managers  with  scientific  and  technical  support  in  areas  falling  under  EFSA’s 

competence 

•  Communicating to the public on matters falling under EFSA’s competence and in particular on EFSA’s 

outputs and the information on which they are based;  

•  Developing  and  applying  uniform  methodologies  for  fit-for-purpose  scientific  advice  on  questions 

related to food safety;  

•  Collecting and analysing data to allow the identification, characterisation and monitoring of current 

risks that have a direct or indirect impact on food safety;  

•  Cooperating with Member States, institutional partners and other interested parties/stakeholders48 in 

the EU to promote coherent advice and increase trust in the EU food safety system;  

• 

Identifying emerging risks to food safety and contributing to a high level of protection of human life 
and health. 

EFSA’s specific competences include: 

•  Risk Assessment in the areas within the EFSA’s remit: Chemicals, micro-organisms, environment, 

plant health and plant protection, animal health and animal welfare, occupational; 

•  Efficacy Assessment, particularly in the area of feed additives; 
•  Chemistry, including chemical characterisation, and molecular characterisation; 
•  Animal sciences: Animal nutrition, Animal production, Animal pathology, Animal welfare; 
•  Environmental sciences; 
•  Food Sciences; 
•  Human sciences: Human medicine, nutrition; 
•  Plant sciences: plant pests, plant health, plant products, biodiversity, food security; 
•  Hazard Assessment: Human and veterinary toxicology, ecotoxicology and environmental fate; 

47 The phrase ‘food safety’ is used throughout the document as shorthand for ‘food and feed safety, animal health and welfare, plant 

health, nutrition and environmental issues specific to the above’ 

48 As defined in EFSA’s founding regulation (Regulation (EC) No 178/2002), Article 3(13) 

42 

 
 
 
 
 
 
 
•  Human exposure assessment, including dietary, non-dietary and cumulative; 
•  Data  collection,  data  and  information  management:  Zoonoses,  Foodborne  diseases,  Food/Feed 

Contaminants, Pesticides and Veterinary medicine residues, Systematic literature reviews; 

•  Risk assessment methodological development; 
• 

Identification of emerging risks, Foresight and Horizon scanning, Early Warning systems. 

The scientific work related to risk assessment is entrusted to ten EFSA Scientific Panels and the Scientific 
Committee:  

•  Panel on Additives and Products or Substances used in Animal Feed (FEEDAP). Provides scientific 
advice on the safety and/or efficacy of additives and products or substances used in animal feed. The 
Panel evaluates their safety and/or efficacy for the target species, the user, the consumer of products 
of  animal  origin  and  the  environment.  It  also  looks  at  the  efficacy  of  biological  and  chemical 
products/substances intended for deliberate use in animal feed. 

•  Panel on Animal Health and Welfare (AHAW). Provides scientific advice on all aspects of animal 

diseases and animal welfare. Its work chiefly concerns food producing animals, including fish. 

•  Panel on Biological Hazards (BIOHAZ). Provides scientific advice on biological hazards in relation 
to  food  safety  and  food-borne  diseases.  This  covers  animal  diseases  transmissible  to  humans; 
transmissible  spongiform  encephalopathies; food microbiology; food  hygiene  and  associated  waste 
management issues. 

•  Panel  on  Food  Contact  Materials,  Enzymes  and  Processing  Aids  (CEP).  Evaluates  the  safety  of 

chemical substances added to food or used in food packaging, and related processes. 

•  Panel on Contaminants in the Food Chain (CONTAM). Provides scientific advice on contaminants in 
the  food  chain  and  undesirable  substances  such  as  natural  toxicants,  mycotoxins  and  residues  of 
unauthorised substances. 

•  Panel on Food Additives and Flavourings (FAF). Evaluates the safety of chemical substances added 
to food and consumer exposure to them. The Panel's work mainly concerns substances evaluated by 
EFSA before their use can be authorised in the EU. 

•  Panel on Genetically Modified Organisms (GMO). Provides independent scientific advice on food and 
feed  safety,  environmental  risk  assessment  and  molecular  characterisation/plant  science.  Its  work 
chiefly concerns genetically-modified plants, micro-organisms and animals. 

•  Panel on Nutrition, Novel Foods and Food Allergens (NDA). Deals with questions related to human 
nutrition, novel foods, nutrient sources, foods for special groups such as infant formulae, health claims 
on food products, dietary reference values, and food allergies. 

•  Panel on Plant Health (PLH). Provides independent scientific advice on the risk posed by plant pests 
which  can  cause  harm  to  plants,  plant  products  or  biodiversity  in  the  EU.  The  Panel  reviews  and 
assesses those risks with regard to the safety and security of the food chain. 

•  Panel on Plant Protection Products and their Residues (PPR). Provides scientific advice on the risk 
assessment of pesticides for operators, workers, consumers and the environment. The Panel develops 
and  reviews  guidance  documents  on  the  risk  assessment  of  pesticides.  This  work  supports  the 
evaluation of active substances used in pesticides, which is carried out Rapporteur Member States and 
peer reviewed by EFSA staff. 

•  Scientific Committee. Develops harmonised risk assessment methodologies on scientific matters of a 
horizontal nature in the fields within EFSA's remit where EU-wide approaches are not already defined. 
It provides general co-ordination to ensure consistency in the scientific opinions prepared by EFSA's 
Scientific Panels. It also provides strategic scientific advice to EFSA’s management. 

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2.  EUROPEAN CHEMICALS AGENCY 

The European Chemicals Agency (ECHA) implements the EU’s chemicals legislation to protect human health 
and the environment. ECHA’s core competence, is to deliver scientifically sound and consistent regulatory 
outcomes that meet EU chemicals policy objectives in a transparent, professional, independent and efficient 
manner.  

ECHA’s scientific competences cover the areas of chemical hazard and risk assessment, identifying the most 
effective risk management option(s), assessing alternative substances and socio-economic consequences of 
risk management decisions. ECHA covers the area of hazard assessment for industrial chemicals, pesticides 
and  biocides;  risk  assessment  of  industrial  chemicals;  use  and  exposure  to  chemicals  other  than  food  and 
medicines. 

ECHA’s specific competences include: 

•  Chemistry, including substance identification and phys chem properties 
•  Hazard assessment – toxicology, ecotoxicology and environmental fate 
•  Derivation of limit values 
•  Alternative methods to animal testing (for example, QSARs) 
•  Exposure and risk assessment 
•  Risk management 
•  Data and information management in relation to chemicals management 
•  Consensus building and delivery of scientific opinions 
•  Delivery of regulatory decisions 
•  Support duty holders with regulatory obligations 

ECHA has four committees and the enforcement forum:  

•  Committee for Risk Assessment. Prepares the opinions of ECHA related to the hazards and risks of 
substances  to  human  health  and  the  environment  for  the  harmonised  classification  under  CLP,  for 
restrictions and authorisations under REACH and for the occupational exposure limits under worker 
protection legislation.  

•  Committee  for  Socio-Economic  Analysis.  Prepares  the  opinions  of  ECHA  related  to  the  socio-
economic impact of possible legislative actions on chemicals in restriction and authorisation processes 
under REACH. The final decisions are taken by the European Commission. 

•  Member  State  Committee.  The  Member  State  Committee  (MSC)  participates  in  several  REACH 
processes such as evaluation and authorisation. The MSC is responsible for resolving divergences of 
opinions among Member States and on proposals for the identification of Substances of Very High 
Concern  (SVHCs).  The  Committee  provides  opinions  on  ECHA's  draft  recommendation  for  the 
authorisation list (Annex XIV) and draft Community Rolling Action Plan (CoRAP) for the substance 
evaluation  process.  If  an  agreement  is  not  reached  within  the  MSC,  the  matter  is  referred  to  the 
European Commission for decision-making.  

•  Biocidal Product Committee. Prepares the opinions of ECHA related to the following processes under 

biocidal product regulation:  

o  Applications for approval and renewal of approval of active substances 
o  Review of approval of active substances 
o  Applications for inclusion in Annex I of active substances meeting the conditions laid down 

in Article 28 and review of the inclusion of such active substances in Annex I 
Identification of active substances which are candidates for substitution 

o 
o  Applications for Union authorisation of biocidal products and for renewal, cancellation and 

amendments of Union authorisations, except where the applications are for administrative 
changes 

o  Scientific and technical matters concerning mutual recognition in accordance with Article 38 

44 

 
 
 
 
o  At the request of the Commission or of the Member States, the BPC is also responsible for 
preparing an opinion on any other questions that may arise from the operation of the BPR 
relating to risks to human or animal health or the environment, or to technical guidance. 

•  Enforcement Forum. A network of authorities responsible for the enforcement of the REACH, CLP, 
and  PIC,  POP  and  Biocidal  Product  regulations  in  the  EU,  Norway,  Iceland  and  Liechtenstein.  It 
coordinates  enforcement  strategies,  proposes,  coordinates  and  evaluates  harmonised  enforcement 
projects and joint inspections, it provides advice on enforceability of regulatory measures and provides 
harmonised practices and training. 

45 

 
 
 
 
 
3.  EUROPEAN MEDICINES AGENCY  

The European Medicine Agency (EMA) is responsible for coordinating the existing scientific resources put at 
its disposal by Member States for the evaluation, supervision and monitoring of medicinal products.  

The Agency’s specific competences include:  

•  providing scientific advice to medicine developers; 

• 

• 

• 

• 

• 

evaluating applications for orphan designation (medicines for rare diseases); 

assessing paediatric investigation plans, which determine the studies that medicines developers must 
carry out in children; 

coordinating the scientific evaluation of applications for centralised marketing authorisations of 
human and veterinary medicinal products in the European Union, based on an evaluation of their 
quality, safety and efficacy; 

advising on maximum allowed concentrations for residues of veterinary medicinal products or 
biocidal products for use in animal husbandry which may be accepted in foodstuffs of animal origin 
(MRLs) 

coordinating inspection for the verification of compliance with the principles of good manufacturing 
practice, good laboratory practice, good clinical practice and pharmacovigilance obligations; 

•  publishing information on authorised medicinal products and potential adverse reactions; 

• 

• 

• 

coordinating pharmacovigilance monitoring systems on all authorised medicines in the EU; 

assisting EU countries with communication to healthcare professionals and patients; 

creating and maintaining a web-portal on medicinal products and their approved uses accessible to 
the general public; and ensuring that it is updated, and managed independently of pharmaceutical 
companies; the database facilitates the search for information already authorised for package leaflets;  

•  development of scientific guidelines on the requirements for quality, safety and efficacy testing of 

medicines; 

•  promotion of alternative methods to animal testing; 

• 

• 

environmental risk assessment (ERA) of active pharmaceutical ingredients; 

supporting the development of new medicines and treatment approaches to respond to antimicrobial 
resistance; promoting responsible use of existing antibiotics; collecting antimicrobial consumption 
data to guide policy and research; 

•  managing shortages medicines and medical devices and supporting medicine development, approval 

and monitoring in preparation for and during public health emergencies. 

EMA has seven scientific committees and a number of working parties and related groups which conduct the 
scientific work of the Agency: 

•  Committee for Medicinal Products for Human Use (CHMP). Responsible for preparing the opinions 
of the Agency on any question relating to the evaluation of medicinal products for human use; 

•  Pharmacovigilance Risk Assessment Committee (PRAC). Responsible for assessing and monitoring 

the safety of human medicines.  

•  Committee for Veterinary Medicinal Products (CVMP). Responsible for preparing the opinion of the 

Agency on any question relating to the evaluation of medicinal products for veterinary use. 

•  Committee for Orphan Medicinal Products (COMP). Responsible for recommending orphan 

designations of medicines for rare diseases. 

46 

 
 
 
 
•  Committee on Herbal Medicinal Products (HMPC). Responsible for compiling and assessing 

scientific data on the recommended use and safe conditions of use of herbal substances, preparations 
and combinations, to support the harmonisation of the European market. 

•  Committee for Advanced Therapies (CAT). Responsible for assessing the quality, safety and 

efficacy of advanced therapy medicinal products (ATMPs) and following scientific developments in 
the field. 

•  Paediatric Committee (PDCO). Responsible for activities on medicines for children and to support 
the development of such medicines in the European Union by providing scientific expertise and 
defining paediatric needs. 

47 

 
 
 
 
4.  EUROPEAN ENVIRONMENT AGENCY  

The European Environment Agency (EEA) is mandated to provide the Community and the Member States 
with the objective, reliable and comparable information at European level and with the necessary technical and 
scientific support, enabling them to take the requisite measures to protect the environment, to assess the results 
of such measures and to ensure that the public is properly informed about the state of the environment. For 
these purposes, the Agency:  

•  maintains the network of national information networks, the national focal points and the topic centres; 

• 

• 

• 

collects, processes and analyses data used in the implementation of EU environmental policy including 
chemicals emission data to water and air, and chemical monitoring data in surface waters, groundwater 
and ambient air; 

assists  the  monitoring  of  environmental  measures  through  appropriate  support  for  reporting 
requirements; 

records, collates and assesses data on the state of the environment; draws up expert reports on the 
quality, sensitivity and pressures on the environment within the territory of the Community, provides 
uniform assessment criteria for environmental data to be applied in all Member States; develops further 
and maintain a reference centre of information on the environment;  

•  helps ensuring that environmental data at European level are comparable and encourages improved 

harmonisation of methods of measurement;  

•  promotes  the  incorporation  of  European  environmental  information  into  international  environment 
monitoring programmes such as those established by the United Nations and its specialised agencies; 

• 

• 

• 

• 

• 

stimulates the development and application of environmental forecasting techniques so that adequate 
preventive measures can be taken in good time; 

stimulates the development of methods of assessing the cost of damage to the environment and the 
costs of environmental preventive, protection and restoration policies; 

stimulates the exchange of information on the best technologies available for preventing or reducing 
damage to the environment; 

ensures the broad dissemination of reliable and comparable environmental information, in particular 
on  the  state  of  the  environment,  to  the  general  public  and,  to  this  end,  to  promote  the  use  of  new 
telematics technology for this purpose; 

supports  the  Commission  in  the  process  of  exchange  of  information  on  the  development  of 
environmental assessment methodologies and best practice; 

•  assists  the  Commission  in  the  diffusion  of  information  on  the  results  of  relevant  environmental 

research and in a form which can best assist policy development 

EEA’s specific competences include: 

•  collecting, processing and analysis of environmental data at European level; 

•  providing and maintaining an efficient reporting infrastructure for data flows and supporting members 

countries in reporting data; 

•  Collecting, maintaining and making publicly available datasets on emissions of pollutants to air and 
water, and on pollutants in ambient air, surface waters, groundwater and drinking water. Collecting 
data reported by companies on the production, import, export, destruction and feedstock use of F-gases 
in the EU assessing the state of the European environment, and climate, including assessments of the 
overall impact of chemical pollution on the environment and human health in Europe; 

•  Communicating environmental and climate change information to citizens; 

48 

 
 
 
 
•  Producing  evidence-based  knowledge  to  support  policy  implementation  and  development  of  new 
initiatives  to  accelerate  and  scale  up  the  transition  to  sustainability.  Delivering  targeted  inputs  to 
inform  policy  and  public  discussions,  by  organising  and  communicating  knowledge  on  responses, 
including innovative solutions to societal challenges. 

EEA coordinates at EU level the European Environment Information and Observation Network (EIONET). It 
consists  of  the  EEA’s  member  countries  (27  EU  Member  States  plus  Iceland,  Liechtenstein,  Norway, 
Switzerland  and  Türkiye) and  cooperating  countries (Albania,  Bosnia  and  Herzegovina,  North  Macedonia, 
Montenegro,  Serbia  and  Kosovo).  The  network  brings  together  around  2000  experts  from  more  than  400 
national institutions that have expertise in environmental issues. The EIONET network has the following roles 
and functions: 

•  National Focal points – nominated and funded by countries to act as primary links between the EEA 
and their country. NFPs organise and develop their country’s Eionet network, as well as facilitate and 
coordinate contacts, requests and information delivery at national and EU levels. 

•  National  Data  Flow  Coordination  –  ensures  a  coherent  and  coordinated  overview  of  collecting, 
collating and sharing data between the country and the EEA to respond efficiently to the needs of the 
Agency's work programme. 

•  EIONET groups – work with the EEA and European Topic Centres to assess Europe’s environment 
and climate, and any related impacts on health and ecosystems. Currently there are 13 Eionet Groups, 
several of them supported by Thematic Groups: 

o  Biodiversity and ecosystems - integration of knowledge for policies 
o  Biodiversity and ecosystems - cumulative pressures and solutions 
o  Circular economy and resource use 
o  Climate change impacts, vulnerability and adaptation 
o  Climate change mitigation and energy systems 
o  Communications 
o  Data, technologies and digitalisation 
o  Food systems 
o  Foresight 
o  Human health and the environment 
o  Land systems 
o  Mobility systems 
o  State of the environment 

•  European Topic Centres (ETC) – are thematic expertise centres contracted and funded by the EEA 
for tasks identified in the EEA-EIONET Strategy. These are designated by the EEA management board 
following a European-wide competitive selection process. The topic centres support the EEA in the 
processing and analysis of the data received from Member Countries. As of 2023, there are 7 topic 
centres working with EEA and national EIONET partners: 

o  ETC on Biodiversity and Ecosystems 
o  ETC in Circular Economy and Resource Use 
o  ETC on Climate Change Adaptation and LULUCF 
o  ETC on Climate Change Mitigation  
o  ETC on Data Integration and Digitalisation  
o  ETC on Human Health and the Environment  
o  ETC on Sustainability Transitions 

49 

 
 
 
 
5.  EUROPEAN AGENCY FOR SAFETY AND HEALTH AT WORK 

The European Agency for Safety and Health at Work (EU-OSHA) provides the Union institutions and bodies, 
the Member States, the social partners and other actors involved in the field of safety and health at work with 
relevant technical, scientific and economic information and qualified expertise in the field of safety and health 
at work in order to improve the working environment as regards the protection of the safety and health of 
workers. 

To that end, EU-OSHA enhances and disseminates knowledge, provides evidence and services for the purpose 
of policy making, including research-based conclusions, and facilitates knowledge sharing among and between 
Union and national actors. 

The EU-OSHA does this by developing, gathering and providing reliable and relevant information, analysis and 
tools to advance knowledge, raise awareness and exchange occupational safety and health (OSH) information 
and good practice which will serve the needs of those involved in OSH. Concretely, the EU-OSHA: 

• 

collects and analyses technical, scientific and economic information on safety and health at work in 
the Member States in order to: 

o 

identify risks and good practices as well as existing national priorities and programmes;  

o  provide the necessary input to Union priorities and programmes; and  

o  disseminate  that  information  to  the  Union  institutions  and  bodies,  the  Member  States,  the 

social partners and other actors involved in the field of safety and health at work;  

• 

collects and analyses technical, scientific and economic information on research into safety and health 
at work and on other research activities which involve aspects connected with safety and health at 
work and disseminate the results of the research and research activities;  

•  promotes and supports cooperation and exchange of information and experience amongst the Member 
States in the field of safety and health at work, including information on training programmes;  

•  organises conferences and seminars and exchanges of expertise from the Member States in the field 

of safety and health at work; 

• 

supplies  the  Union  institutions  and  bodies  and  the  Member  States  with  the  objective  technical, 
scientific and economic information available and the qualified expertise they require to formulate and 
implement judicious and effective policies designed to protect the safety and health of workers; 

•  provides forums for exchange of experiences and information between the governments, the social 

partners and other stakeholders at national level;  

• 

• 

contributes,  including  through  evidence-based  information  and  analyses,  to  the  implementation  of 
reforms and policies at national level;  

collects and makes available information on safety and health matters from and to third countries and 
international organisations;  

•  provides  technical,  scientific  and  economic  information  on  methods  and  tools  for  implementing 
preventive  activities,  identify  good  practices  and  promote  preventive  actions,  paying  particular 
attention to the specific problems of MSMEs and, with regard to good practices, focuses, in particular, 
on practices which constitute practical tools to be used in drawing up an assessment of the risks to 
safety and health at work, and identifying the measures to be taken to tackle those risks;  

• 

contributes to the development of Union strategies and action programmes relating to the protection 
of safety and health at work, 

• 

establishes a strategy for relations with third countries and international organisations;  

50 

 
 
 
 
 
• 

carries out awareness raising and communication activities and campaigns on safety and health at work 
issues. 

EU-OSHA’s specific competences include: 

•  Competence in occupational safety and health as regards the workplace management of dangerous 
substances (this  includes  registered  chemicals and process-generated  substances  and mixtures (e.g. 
silica dust, welding fumes, diesel motor emissions or wood dust)) 

•  Development of tools for the management of dangerous substances at the workplace level and sectoral 

workplace risk assessment tools (OiRA) 

•  Collecting information on national tools and guidance and examples of good practice regarding the 

management of dangerous substances at work. 

•  Development of information and awareness-raising campaigns in the area of dangerous substances at 

work 

•  Collecting and analysing technical and scientific information in the area of dangerous substances at 

work and related health problems and publishing the results  

•  Development  of  surveys  targeting  exposures  at  workplaces,  e.g.  the  Workers´  exposure  survey  on 

cancer risk factors in Europe 

•  Supporting the European Commission, for instance through the development of guidance in the area 

of dangerous substances management and OSH 

The EU-OSHA maintains a network that comprises the main components of the national information networks, 
including the national employers’ and employees’ organisations and the national focal points. 

•  Network of national Focal Points and Member State tripartite networks: in accordance with the 
founding regulation of EU-OSHA, the national authorities or a national institution designated by the 
Member State as a national focal point coordinates and transmits the information to be supplied at 
national level to EU-OSHA within the framework of an agreement between each focal point and EU-
OSHA on the basis of the work programme adopted by EU-OSHA. The national authorities or national 
institution  shall  consult  the  national  employers'  and  employees'  organisations  and  shall  take  into 
account their point of view in accordance with national law or practice. The Member States regularly 
inform EU OSHA of the main components of their national safety and health at work systems and 
strategies.    This  network  provides  input  to  EU-OSHA’s  work  and  the  mechanism  to  disseminate 
products  and  information  to  national  stakeholders.  In  addition,  the  focal  points  are  active  in  the 
planning and implementation of EU-OSHA campaigns as well as nominating national experts to the 
Agency’s groups and seminars. 

•  Close functional links with the Advisory Committee on Safety and Health at Work and its working 

parties and the Senior Labour Inspectors Committee and its working groups 

51 

 
 
 
 
 
ANNEX  II:  SUMMARY  OF  THE  FEEDBACK  RECEIVED  THROUGH  THE 
PUBLIC  CONSULTATION  ON  THE  CALL  FOR  EVIDENCE  FOR  THE 
INITIATIVE  ON  (RE-)ATTRIBUTION  OF  SCIENTIFIC  AND  TECHNICAL 
WORK ON CHEMICALS TO THE EU AGENCIES 

The call for evidence was published on the Commission’s website ‘Have your say’ on 15 March 2022 and the 
feedback period lasted 30 days, until 12 April 2022.  

1.  RESPONDENTS 

In  total,  65  submissions  were  received  (61  unique  submissions  and  4  replicative  submissions  by  the  same 
respondent), majority being from business associations and companies (in total around 70% of submissions), 
followed by submissions from EU citizens (11%), non-governmental organisations (6%), public authorities 
(6%), others (5 %) and academic/research institutions (1.5%). 

Proportions of number of feedbacks received by category of respondents 

As  regards  geographical  variation, the majority  of  feedback  was  received from respondents  from  Belgium 
(49%),  followed  by  Germany  (17%),  Poland  (8%),  France  (6%),  Spain  and  Denmark  (3%  each)  and  UK, 
Sweden, Slovakia, Portugal, Norway, Japan, Italy, Finland and Austria (2% each).  

2.  TYPE OF RESPONSES 

Large majority of responses were relevant to the topic of the call for evidence. Only 3 responses were assessed 
as not relevant to the 1S1A. They provided specific comments on the ongoing revisions of some pieces  of 
legislation but without relevance to the 1S1A or just a general critisism of the EU legal framework.  

As this has been the first public consultation on an initiative under the 1S1A, a lot of feedback received was 
not specific about the consulted initiative on the reattribution of task to the EU Agencies but about the general 
scope of the 1S1A approach as well as other initiatives announced under the 1S1A. All feedback received is 
however useful for the upcoming discussions, therefore, the text below summarises all relevant input received.  

3.  SUPPORT TO THE INITIATIVE ON 1S1A 

Generally, there is a large support of the initiative among the respondents, whether of the 1S1A approach as a 
whole or of the specific initiative on the reattribution of tasks. 67% of respondents expressed their explicit 
support, 23% did not expressed explicitely their opinion but provided relevant advices on how to develop the 
1S1A  approach  and  about  10%  expressed  doubts  about  usefulness  of  the  initiative  or  opposition  to  the 
initiative.  

52 

 
 
 
  
 
The well-implemented 1S1A initiative is seen by respondents as beneficial for both industry and regulators. 
The respondents supporting the initiative identified the following benefits of the initiative:  

-  More uniform risk assessment across relevant chemical legislation; enhanced consistency of assessments 

and their outcomes, carried out on the same dataset; 

Improved robustness of the assessments; 

Involvement of the right expertise at the right place at the right time; 

- 

- 

-  Provision of tailored assessments under specific legislations/uses if relevant; 

-  Optimal use of resources;  

- 

Increased efficiency and predictability; 

-  Making use of synergies (phys/chem/tox data available at different EU agencies); 

-  Elimination of duplication of animal testing in the EU and a driver for both improved sustainability and 

better protection of animals; 

-  Strengthening trust between society and industry, whilst improving efficiency, and sound science-based 
regulatory  and  political  decision-making;  achieving  a  robust  and  consistent  approach  to  chemical 
regulation;  

Some respondent identified concrete past and on-going discrepancies and ineficiencies as regards the safety 
assessment of chemicals that they hope to be avoided by the implementation of the 1S1A initiative. These are: 

-  Past  discrepancy  in  assessments  of  phthalates  and  bisphenols  between  ECHA  and  EFSA  and  between 

REACH and Food Contact Materials; 

-  On-going  discrepancy  in  risk  management  measures  on  silicon  dioxide  under  the  biocidal  product 
regulation  (where  there  is  a  low  limit  on  its  presence  in  biocidal  products)  and  REACH  (where  this 
substance  is  exempted  from  information  requirements  and  can  be  sold  in  products  at  much  higher 
concentrations than in the biocidal products); 

-  Currently no link exists between the REACH and Food Contact Material legal framework as regards the 
re-use of data, although the same substances are being regulated under both frameworks. On the chemical 
side,  over  ten  years  of  REACH  implementation  led  to  the  generation  of  a  very  comprehensive 
(eco)toxicological dataset on a wide number of substances, which is available to ECHA. It would be very 
efficient and avoid unnecessary test and the repetition of studies, especially in vivo (animal studies), if this 
data could be used for the risk assessment in the FCM framework by EFSA. Although the robust study 
summaries provide some publicly available data, like toxicological end points, this is often not accepted by 
authorities as the original studies behind the end points are requested, which cannot be accessed by the 
authorities.  Therefore,  the  link  needs  to  be  established  between  these  two  legislation  and  the  legal 
framework around the usage of such data should be modified and broadened to facilitate the reuse of already 
available data and to allow other Agencies to access the REACH data. 

-  There is a need for an improved vertical coordination and collaboration between the expert panels of EFSA 
evaluating the same substance. Challenges have previously been seen for e.g. fluoride, evaluated by the 
EFSA  nutrition  panel  but  where  the  contaminants  panel  is  also  relevant.  For  chemical  substances  like 
fluoride  it  is  important  that  an  evaluation  covers  both  aspects  of  nutrition  and  toxicology.  For  some 
contaminants we have also seen that JECFA and EFSA have evaluated the same substance with different 
output/result. It would improve the use of resources if it were not necessary to have two different bodies 
evaluating  the  same  substance.  However,  as  Codex  Alimentarius  refer  to  JECFA  evaluations  and  EU 
Commission to EFSA evaluations it will be challenging to accept/adopt the evaluation made by the other 
Committee. 

-  Currently, there is no central searchable database on environmental impacts of pharmaceuticals available. 
Therefore, it is proposed to integrate the validated environmental information on pharmaceuticals held by 
EMA in data platforms already used on a European level. The central database would also be a valuable 
tool for endpoints of monograph systems for human and veterinary pharmaceuticals. 

The respondents opposing or doubting the initiative provided the following arguments:  

53 

 
 
-  Did  not  observe  problems  with  ‘duplication’  or  ‘inconsistent  outcomes’,  although  the  substances  they 

produce/use fall within various regulatory domains; 

-  The initiative is likely to create more complexity, as well as a transition period which will considerably 
affect  substance  evaluation  and  authorization  processes  and  timelines,  as  well  as  the  burden  placed  on 
applicants. The latter will come on top of the increased complexity created by the recent implementation 
of the Transparency Regulation and its requirements related to confidentiality justification and the new IT 
tools to be used for notification and submission of dossiers to EFSA and the Commission. 

-  Several product specific regulations require special product qualities like e.g. a high purity and consider 
very specific exposure possibilities.  The general goal of true “one substance,  one assessment” is highly 
difficult to implement, taking into account all possible applications and the various grades of a substance 
on the market. The assessment of a substance requires a high level of expertise and detailed considerations. 

- 

It is important that chemicals used in the EU are assessed by several independent research teams, which 
will reduce the risk of lobbying and increase the possibility of comparing test results.  

Some  confusions  or  misunderstandings  could  be  observed  in  some  of  the  responses  provided.  The  most 
common ones are:  

-  Some respondents considers that ECHA does only hazard assessment while EFSA does risk assessment. 
The true is that both agencies do both, hazard and risk assessment. The confusion might originates from the 
fact that ECHA does also harmonised classification of hazards under the CLP regulation, which is pure 
hazard assessment, and respondents are not aware of their risk assessment work as part of the REACH 
restriction process or implementation of the biocidal product regulation, POPs regulation or drinking water 
directive. 

-  Some respondents fear that moving some assessments to ECHA will automatically result in hazard-based 
regulation,  omitting  the  use  of  exposure  information.  The  true  is  that  reattribution  of  tasks  on  safety 
assessment will not change the risk management measures. In addition, as explained above, ECHA is also 
doing risk assessments and has experience in doing so. 

-  Some respondents fear of the ambition to create one new ‘risk assessment’ agency and consolidating all 
risk assessments into such agency. There is no such intention. The objective of 1S1A initiative is to improve 
cooperation between agencies and clearly distribute the relevant tasks among them with the objective to 
improve coherence, efficiency and effectiveness of safety assessments.  

4.  SCOPE AND OBJECTIVES OF 1S1A 

Number of respondents provided their views and expectations regarding the scope and objectives of 1S1A.  

The expectations and views expressed by the respondents regarding the general scope and objective of the 
1S1A are as follows:  

-  1S1A should ensure that the level of protection for the human health and the environment is not jeopardised 

and remains high. 

-  1S1A should work towards a coherent protection goals by developping a new EU Human Health Directive 
that aims to achieve ‘good public health’, protecting humans from the combined action of chemicals and 
combined action of chemicals and non-chemical environmental stressors.  

-  1S1A  should  be  limited  to  one  substance,  one  hazard  assessment.  The  hazard  assessment  –  the  basic 
evaluation of substance properties – should be grounded in a single set of agreed scientific principles, as it 
is  independent  of  the  area  of  application  or  legislation.  Risk  assessments  and  potential  socio-economic 
assessment however should remain tailored to their different purposes and legislation, taking into account 
the use of, the exposure to the substance and particularities of the sector. Risk management measures should 
be also specific and tailor-made.  

-  1S1A should ensure that for a specific use there is only one risk assessment performed across legislation 

valuing existing expertise.  

-  1S1A should ensure that all relevant assessments are updated if new data and new assessment lead to a new 
TDI or PNEC value to ensure that all regulations rely on limit values derived from the latest knowledge. It 

54 

 
 
should be considered in the new omnibus regulation to require updates in all sector specific regulations 
within a given timeframe when a new TDI or PNEC value is derived by an EU scientific committee. 

-  The actions of 1S1A initiative should be focused on where duplication really appears, i.e. to  

o  hazard  assessment  and  classification,  identification  of  acute  concentration  limits  ATEs,  local 
effects  specific  concentration 
limits  SCLs  and  NOAELs/LOAELs  for  human  health, 
ECxx/LCxx/NOECs for acute aquatic toxicity and other wildlife. Based on these endpoints, the 
derivation of DNEL/OEL/TDI/ADI/PNECs/EQs, etc. may differ between legislations (REACH, 
OSH, PPR, BPR, FCM, WFD) due to different methodologies to carry out their safety assessment. 

o  substances used in different applications covered by different legislation.  

-  Although 1S1A is targeting on ‘chemicals’, it should be expanded also to microbials, natural substances 
and semiochemicals used as biocontrol. Biocontrol products themselves may be used for more than one 
purpose;  for  example,  micro-organisms  are  used  in  the  area  of  crop  protection,  but  also  as  fertiliser  or 
biostimulant under Fertilizer Product Regulation. The same micro-organism are used in agriculture and are 
subject to different regulatory frameworks and thus to different sets of data requirements and procedures. 
Ultimately this may lead to different and even contrary decisions, based on the same data package the same 
micro-organism may be authorised for one area of use (e.g. as a biostimulant), but may not be approved for 
another  area  of  use  (e.g.  crop  protection).  Establishing  within  the  EU  a  group  of  biocontrol  experts  is 
recommended. To start, the group should consist of microbial experts from Member States, EFSA, ECHA, 
and  other  relevant  EU  institutions  that,  in  close  cooperation  with  COM,  will  be  responsible  for  all 
evaluations and assessments of microbial active substances submitted in the EU for approval. This would 
guarantee a consistent and scientifically sound approach that would considerably simplify and speed up 
procedures. This should then be extended to cover experts in natural substances and semiochemicals. 

-  1S1A should also aim to improve comparability of monitoring data across Member States in the area of 
food contaminants. Pursuant to Commission Regulation (EC) No 1881/2006, Member States are requested 
to examine samples and provide necessary data that could lead to a comprehensive risk assessment. Despite 
the European scope of the risk assessment, means to support such data collection is still largely maintained 
at a Member State level, manpower and the financial means of Member States for this varies, which all 
together may lead to national authorities providing data with high variability. This initiative on streamlining 
scientific  assessments  is  an  opportunity  for  the  Commission  to  support  the  integral  role  that  national 
authorities and European Reference Laboratories do to ensure the conclusions taken from these studies and 
guidance documents are as robust as possible. 

-  Some respondents argued that veterinary medicinal product should be exlcuded from the scope of 1S1A, 
while others were arguing for importnace to include also medicinal products, in particular as regards the 
environmental data on medicinal and veterinary products. 

The expectations and views expressed regarding the five specific areas of the 1S1A initiative identified in the 
chemicals strategy for sustainability are as follows: 

Coordination and initiation of the assessments 

-  Upfront  close  coordination  of  assessments  should  be  established  across  different  DG’s,  Scientific 
committees (including Scientific Panels), Agencies as well as Member States at European level, to decide 
what is required, and who does what and when; 

-  A  central  coordination  mechanism  should  be  established,  including  a  coordinated  problem  formulation 
phase  (i.e.  identifying  the  correct  scientific  question  that  needs  to  be  answered)  which  would  enhance 
predictability for industry; 

-  Mechanisms  needs  to  be  created  to  integrate  assessments  that  specify  the  health  and  environmental 

endpoints used by the different agencies; 

-  Different  bodies  active  in  the  assessment  of  chemicals  must  ensure  proper  coordination  of  their  work, 
especially when they are assessing the same substance. This includes an exchange of information such as 
results of previous assessments.  

-  Also the national authorities of each EU member state that should be active in the assessment of chemicals, 
e.g.  under  REACH,  are  included  in  the  “one  substance,  one  assessment”  initiative  in  order  to  prevent 
diverging  views  between  member  states  and/or  EU  authorities  regarding  the  assessment  of  (groups  of) 
chemicals. 

55 

 
 
- 

It is vital that the implementation of the “one substance, one assessment” approach contains provisions for 
supporting greater interagency cooperation; 

-  To make this system work it is recommended that evaluators/risk assessors from different regulatory bodies 

attend each other meetings thus ensuring consistency and avoiding duplication of work;  

-  Cooperation between EU and national agencies is crucial for a better usage of resources.  

- 

It shall be avoided that overlapping evaluations and assessments are taking place in parallel within the same 
regulatory context. Risk management measure processes should not be started during an on-going substance 
evaluation,  where  data  gaps  may  be  identified  and  therefore  pre-empting  the  step  in  the  substance 
evaluations that identifies the most appropriate risk management measures to be identified or data to be 
gathered to be available; 

Allocation of responsibilities 

-  Tasks  should  be  reattributed  amongst  the  agencies  to  ensure  efficiency,  by  assigning  the  relevant 

responsibilities to the pertinent agency rather than reshuffling already established responsibilities;  

-  Each body (i.e. authority, agency, working group, etc.) that is carrying out an assessment of (groups of) 
chemicals should be equipped with sufficient expertise necessary for the specific assessment, e.g. in the 
field of toxicology, ecotoxicology, occupational safety and health, exposure assessment, etc  

-  Cooperation between EU and national authorities should be also optimized. Synergies and overlaps must 

be clearly identified. This area is not left out and there is a clear division of tasks. 

Data 

-  Data exchange across Committees and Agencies should be ensured to avoid duplication of data submission; 
a common information base needs to be created to avoid duplication of assessments, for example with an 
open data platform on chemicals and tools for accessing relevant academic data; 

-  Exposure assessment tools and methodology could also be centralised on a common data platform; 

-  Access to all available data in the same structured format should be provided for all EU authorities. Equal 

transparency regimes are applied across all sectors. 

-  Academic data has a role to play in science-based policy making, however, there needs to be a process to 
ensure  that  data  is  reliable  and  robust.  There  are  1000’s  of  studies  related  to  titanium  dioxide  that  are 
published  each  year  and  the  titanium  dioxide  industry  has  a  comprehensive  screening  process  in  place 
including regular updates of the REACH dossier. A lot of the academic data related to titanium dioxide is 
not reliable or robust enough with basic information such as the identity of the substance unknown. The 
other  concern  is  the  inherent  bias  as  non-adverse  outcome  are  less  likely  to  be  published.  The  OECD 
Guidelines for the Testing of Chemicals were developed for this reason, and it is important that they remain 
the key benchmark. 

-  We  strongly  support  the  proposal  to  introduce  new  tools  for  the  1S1A  approach,  which  would  further 

improve the work of the industry and scientific committees in ensuring consumer safety by: 
o  extending the use of the public activities coordination tool to other legislation 
o  establishing an EU repository of human and environmental health-based limit values; and  
o  establishing a common, open data platform on chemicals and tools for accessing relevant academic 

data 

-  We support the principle of harmonizing the format in which data is reported to enable data to be shared 
between  agencies.  A  harmonized  data  format  will  in  our  opinion  lead  to  efficiencies  and  greater 
transparency.  To  us  a  harmonized  data  format  does  not  equal  harmonized  data  requirements  between 
agencies since adequate data required for a risk assessment depends on the sector considered. It would be 
important to have a systematic mechanism supported by the authorities to organize the request of data to 
the manufactures to avoid duplication of efforts/resources and to guarantee a good agreement among the 
interested  parties.  The  format  of  all  data  collected  should  be  developed  in  close  collaboration  with  the 
industry to ensure it is fit for purpose. 

-  We are in favour of promoting the environmental biomonitoring and check how the establishment of that 

limit values could benefit from this biomonitoring. 

56 

 
 
-  The legal framework around the usage of REACH registration data should be modified and broadened to 
allow  other  Agencies  to  access  such  information,  in  order  to  prevent  double  work,  but  above  all  the 
repetition of studies, especially in-vivo, for the same substances. With specific reference to evaluations 
concerning food contact materials, we believe that EFSA would greatly benefit from access to registration 
dossier data, with due consideration of data protection. Similarly, we believe that also MSCA should also 
have access to the existing data. For instance with regards to FCM evaluations, this would enable them to 
make  evaluation  on  the  same  dataset  used  by  EFSA,  uniformizing  the  petitioning  process  by  avoiding 
divergence in the approach. 

-  Environmental  safety  data  already  assessed  by  one  of  the  European  agencies  should  be  available  for 
procedures under different EU regulations. This should also apply to environmental data from the veterinary 
and  human  pharmaceutical  legislation.  Therefore,  including  EMA  as  agency  responsible  for  the 
environmental  impacts  of  pharmaceuticals  is  highly  welcome.  Currently,  there  is  no  central  searchable 
database on environmental impacts of pharmaceuticals available. Therefore, it is proposed to integrate the 
validated  environmental  information  on  pharmaceuticals  in  data  platforms  already  used  on  a  European 
level. The central database would also be a valuable tool for endpoints of monograph systems for human 
and veterinary pharmaceuticals. 

Methodologies 

-  Clear,  standardised  approaches/protocols  on  hazard  and  risk  assessments  must  be  developed  to  ensure 
consistency  and  predictability,  while  acknowledging  the  different  needs  of  the  different  regulatory 
frameworks. For example, in food safety related matters it is crucial to define health-based guidance values 
from the context of food exposure only, and therefore the ways of assessing the hazard might divert from 
other legislative areas where other routes of exposure are more prominent. 

-  The assessment of chemicals must be science-based. 

-  Harmonisation of the methodologies for the assessment of chemicals should incorporate and expand the 
use  of  non-animal  New  Approach  Methods  and  next  generation  risk  assessment  tools  (based  on  the 
knolwdge  acquired  by  SCCS),  making  this  a  default  ‘one  assessment’  framework  applicable  to  all 
chemicals. 

-  Harmonisation  of  evaluation  methodologies  is  needed.  For  example,  the  AOEL  (acceptable  operator 
exposure level), DNEL (derived no-effect level), the MOS (margin of safety) and the OEL (occupational 
exposure limit) are four different ways to set a threshold limit under Pesticides, REACH, the Cosmetics 
Regulation and workplace regulation, respectively. Another example is the methodology used under the 
Water Framework Directive to set environmental quality criteria with the purpose of protecting humans 
from consumption of polluted fish and shellfish. This methodology differs from the methodology used by 
EFSA and national food safety authorities to set limit values for edible fish, thereby resulting in different 
limit values for the same substance. 

Transparency rules 

-  Transparency on the decisions and processes is increased; 

-  All information regarding the evaluating authority, the process and status of the assessment as well as all 

relevant documentation should be available to all stakeholders. 

-  Transparency rules should be also harmonized.  

5.  REATTRIBUTION OF TASKS TO EU AGENCIES 

Number of respondents provided their views on how the reattribution of tasks to the EU agencies should be 
done. These are:  

-  Reattribution of work must not result in a single agency being responsible for the risk evaluations of all 
chemicals. A clear demarcation of responsibilities between relevant EU agencies and regulations is needed.  

-  The role, tasks and expertise of each agency should be clearly defined and exploited in a targeted manner. 

Agencies should stay within their assigned areas of duty and abstain from political interventions. 

Expertise 

57 

 
 
- 

It is strongly suggested that expertise for risk assessment under the different regulations should stay with 
the existing responsible agencies. Each Agency is best positioned to lead and provide specific assessments 
due to their extensive experience in product specific related matters, e.g., EFSA for food use, EMA for 
medicines use.  

- 

It  shall  be  ensured  that  whatever  body  carries  out  the  risk  evaluation  tasks  it  shall  have  available  the 
necessary and adequate expertise within the application domain of the use of the chemicals.  

-  We strongly encourage the Commission to review the functioning of the existing scientific committees, 
agencies, consultants, etc. supporting scientific assessments to ensure that they have the relevant expertise 
(both quantitatively and qualitatively) and always strive for opinions of the highest scientific excellence 
and integrity 

-  Not  all  hazard  endpoints  are  covered  by  all  regulations.  For  the  environment,  the  Plant  Protection 
Regulation is probably the most advanced as requiring testing on species not covered by other regulations 
such  as  honeybees,  earthworms,  plants,  beneficial  arthropods,  birds.  Therefore,  the  derivation  of  these 
endpoints should stay with the Agency having the expertise, i.e. EFSA. 

-  The  reattribution  should  ensure  that  valuable  expertise  gathered  by  existing  entities  is  preserved.  The 
knowledge of SCCS to perform risk assessment without animal use has to be preserved and cosmetics have 
to  continue  use  only  data  from  non-animal  tests.  Transparent  safety  assessment  process  for  cosmetics 
should continue to be underpinned by the use and further development of the current Notes of Guidance 
from SCCS. 

Resources  

-  The necessary resources must accompany new tasks to the agencies.  

-  Re-attribution of work should not lead to the situation that the Agency or committee is not able to handle 
the  workload  and  hence  would  jeopardise  the  quality  of  the  work  or  result  in  the  use  of  scientifically 
unsound decisions/approaches.  

Organisation of scientific committees 

-  Agencies might need to be reorganised to deal with increased workload. RAC in ECHA has already now 
immense workload; In ECHA, MSC could be turned into the hazard assessment committee to deal with 
CLP classification, RAC could focus only on risk assessments. It would be useful to also align panels in 
EFSA as the same substance is evaluated by two panels. 

- 

Instead of creating new scientific panels, the agencies should be supported to be able to reinforce the expert 
independent  committees  and  working  groups  that  already  exist,  with  a  certain  level  of  flexibility  and 
openness in terms of reaching the best assessment. 

-  The safety assessment for consumer products should be performed by an independent commitee which has 
equal  status  to  hazard  assessment  committee  (i.e.  a  safety  assessment  committee  for  consumer  product 
should not report into a hazard assessment committee). 

Tasks to re-attribute  

-  For substances used in food contact materials the process should involve EFSA and ECHA. The process 
should start with the hazard identification and characterization of substances, followed by an FCM specific 
risk assessment. We recommend ECHA play a central role in the hazard assessment of chemicals, while 
EFSA assess risks linked to their use in FCMs (which are highly specific compared to those for other uses 
of chemicals). 

-  So far, a number of tasks have been distributed to ECHA, or are foreseen to be distributed to ECHA. This 
includes e.g. opinions on health based limit values under OSH, derivation of limit values under the Drinking 
Water Directive, evaluation of cosmetic ingredients under the Cosmetic Products Regulation, etc. However, 
other areas have not been addressed such as e.g. derivation of environmental quality standards under the 
Water Framework Directive, or opinions on chemical substances in e.g. toys by the scientific committee 
SCHEER. It should be considered how to achieve harmonization in these areas as well, including if tasks 
should be redistributed to one of the agencies (EFSA or ECHA) 

-  The  proposal  should  include  as  many  substance  regulations  as  possible  within  the  EU  legislative 

framework, e.g. Toys directive, food and feed additives, environmental quality standards (EQS). 

58 

 
 
Impact assessment  

-  Few  respondents  suggested  to  perform  an  impact  assessment  for  the  1S1A  initiative  to  make  sure  that 
potential impacts on business operators are adequately considered and to make sure that businesses are 
involved in the development of the initiative.  

59 

 
 
 
 
ANNEX III: DETAILED IMPACT ANALYSIS OF THE (RE-)ATTRIBUTION OF 
SCIENTIFIC  AND  TECHNICAL  WORK  RELATED  TO  CHEMICALS  TO  EU 
AGENCIES  

1.  DRINKING WATER DIRECTIVE (2020/2184) 

Responsible body: 

Currently: N/A, no current process exists at EU level 

(Re-)attribution planned to: ECHA  

Legal basis for reattribution: Revision of drinking water directive  

Type of task: New 

Brief  task  overview:    Establishing  and  maintaining  four  EU  positive  lists  for  substances  and 
compositions authorised to be used for the manufacture of materials in contact with water intended 
for human consumption.  

Detailed process description:  

Current process: 

N/A, no process exists at EU level 

New process:  

1.   From national lists to the first EU positive lists (review programme) 

The  Commission,  supported  by  ECHA,  compiles  the  first  EU  positive  lists  for  substances  and 
compositions used in the manufacture of organic, cementitious, metallic and inorganic materials in 
contact with water intended for human consumption. These first positive lists are based on national 
positive lists notified to ECHA by July 2021; in addition, the positive list for organic materials will 
incorporate  the  plastic  FCM  positive  list  of  Regulation  (EU)  No.  10/2011.  All  entries  in  the  EU 
positive lists will be subject to a review. To this end, each entry will be accompanied by an expiry 
date by which industry needs to submit an (review) application to ECHA. The burden of proof is with 
industry: if industry wishes to keep a substance or composition on the EU positive list, they need to 
submit  an  application  by  a  specified  deadline.  If  no  application  is  received  by  the  deadline,  the 
substance or composition is removed from the positive list. 

It is estimated that the first EU positive lists will contain approximately 2000 entries with assigned 
expiry dates of 2028, 2031, 2034 and 2037 depending on the hazard of each entry and the availability 
of past risk assessments. The first European positive list will be adopted by January 2024, the first 
review applications can be submitted as from January 2026 and the whole review programme shall 
be finished within 15 years by end December 2039. 

2.   Updating the EU positive list 

Once established, ECHA will need to manage the EU positive lists through the addition, removal and 
updating of entries in the lists. The process can be triggered by: 

a.  An economic operator who wishes to add a substance or composition to an EU positive list 

or has to submit a review application for an existing entry; 

60 

 
 
 
b.  An authority that has a reason to propose removing a substance or composition from an EU 

positive list or to update an entry; 

c.  ECHA, that may submit an application on the Commission’s request. 

Once an application is received, the process at ECHA contains the following main steps: 

•  Automated and manual checks of the application to verify completeness and accordance 
with the information requirements which will be set out in implementing legislation;  

•  Dissemination of information and consultation of interested parties; 

•  Opinion development via the RAC committee; 

•  Support to applicants and Member State Competent Authorities; 

•  Technical and scientific support to the Commission. 

The first review applications can be submitted as from January 2026. 

Proximity to ECHA mandate: 

The work is close to the ECHA core mandate of assessing the risk of chemical substances based on 
industry applications and many of the core competences are already present in the Agency. 

Projected synergies and added value of (re-)attribution: 

Type 

Synergies 

Reuse of 
capabilities 

High 

Process  and  expertise:  ECHA  already  supports  similar  work  on  substance  risk 
assessment  under  REACH  and  other  legislation.  Several  key  capacities  can  be 
reused/reinforced: 

-  Hazard, risk and exposure assessment 
-  Committee opinion development 
-  Existing  IT  capabilities  for  industry  dossier  submission,  stakeholder 

consultation and dissemination 

Re-use of data 

Medium 

Reuse  of  substance  identification  and  hazard  data  collected  under  other  chemical 
legislation. Currently low availability of data on substances in products and no data 
available on migration of substances to water. 

Low 

High 

High 

Workload 
balancing 

IT tools: 
automation and 
economies of 
scale 

Support 
services: 
economies of 
scale 

With an estimated workload of developing 50-150 RAC opinions annually, there is 
little room for workload balancing. 

Industry  actors  can  submit  their  applications  reusing  existing  ECHA  submission 
tools, which will be adapted to the needs of the EU positive lists, at the same time 
automating  the  existing  process.  In  addition,  reuse  of  IT  capabilities  for  case 
management,  public  consultation,  interaction  with  Member  States,  regulatory 
intentions management and data dissemination. 

Reuse  of  scientific  support  services  (e.g.  committee  secretariat,  prioritisation  and 
grouping  of  substances,  substance 
identification,  data  management  and 
dissemination). Reuse of administrative services. 

Type 

Added value 

Scientific 
consistency 

High 

Opportunity  to  align  priority  setting,  timeline,  process  and  methodology  at  EU 
level to improve equal EU market access and coherence in the scientific advice 
provided to the Commission. Reuse of assessment insights developed under other 

61 

 
 
 
 
 
chemical  legislation.  Opportunities  to  put  into  practice  the  One  Substance-One 
Assessment for substances of interest to both drinking water (ECHA) and food 
contact materials (EFSA). 

Robustness 
assessment 
acceptance 

High 

of 
and 

Harmonising market access and scientific work from Member State level to EU 
level. Additional involvement of RAC committee adds more scientific robustness 
to the process. 

Independence 

High 

Moving  scientific  work  from  Member  State  level  to  EU  agency  experts  and 
committees.  ECHA  and  its  committees  work  under  strict  conflict  of  interest 
avoidance  rules,  improving  guarantees  of  independent  scientific  advice  to  the 
Commission. 

Transparency 

High 

ECHA’s involvement will ensure transparency to the process: 

-  Overall process transparency 
-  Publication  of  regulatory  intentions  of  EU  authorities  and  application 

submission intentions improves predictability for all stakeholders 

-  Public consultation/call for evidence 
-  Stakeholder involvement/observer status 
-  Dissemination of scientific data and outcomes 

Main risks and opportunities: The high impact of the work on the RAC committee needs to be 
addressed. 

Projected impact on ECHA: 

•  ECHA Committees/bodies: high impact. The task generates major impact on the setup / 
organisation / staffing of Committees/bodies due to significant additional workload 

RAC 

# of 
opinions 
per year 

rapporteur 

Type of 
opinion 

50-150 

RAC member 

SEAC 

# of 
opinions 
per year 

0 

rapporteur 

Type of 
opinion 

Process 

Assessment of 
applications and 
dossiers 

•  ECHA  data  model  and  IT  infrastructure:  low  impact.  The  task  can  be  implemented  with 

adjustments / configuration of existing data structures and IT systems  

•  ECHA  key  experts:  high  impact.  The  task  heavily  relies  on  existing  expert  competencies 
which are limited within ECHA and also critical to REACH/CLP/BPR regulatory tasks, as 
well  as  new  competencies  which  ECHA  should  acquire  (e.g.  migration  assessment  and 
materials science) 

Workload and resource implications: 

Current workload and resource use: 

N/A, no current process exists at EU level 

Future workload and resource needs: 

The Directive is in force since 2021. Industry can notify their intention to submit an application from 
January 2025 with the first industry applications expected from January 2026 onwards. 

A total of 3 new full-time equivalent temporary agent staff (AD 5-7) (average cost EUR 136 000/year, 
during  4  years)  and  2  full-time  equivalent  contract  agent  staff  (CA  FG  III,  average  cost  EUR  65 
000/year), have been allocated to ECHA to set up the system. After 4 years, the review process will 
necessitate additional resources, i.e. 10 FTE on average for the next 4 years (7 temporary agent staff 
62 

 
 
 
 
 
 
 
 
 
 
 
and 3 contract agent staff). A new assessment of the needs will be completed at the end of the period 
on the basis of the experience gained during the first years of functioning of the system. According 
to first estimates, additional staff (around 3 FTE, i.e. bringing the total to 13 FTEs) might be needed 
to complete the review of all substances on the positive lists in a reasonable deadline (15 years). 

In addition to staff costs, EUR 1 000 000 is reserved for the first 3 years annually to set up the IT 
systems, whereas roughly half of this amount will be needed for maintenance work after the set-up 
period. Infrastructure expenditure has been estimated at 24% of the staff expenditure. 

The aforementioned resources have been estimated using a calculation model which takes account of 
relevant experience from tasks executed by ECHA under other regulatory frameworks (e.g. REACH, 
CLP, BPR) and from the implementation of the existing national approaches where relevant. It sets 
out the resources that will be needed by ECHA over a time window of 20 years, including a review 
programme running over 15 years, in order to handle the foreseen tasks. 

The  estimated  resources  for  the  process  to  review  and  update  the  EU  positive  lists  are 
application/dossier driven. The number of applications/dossiers have been estimated on the basis of 
substances  on  lists  currently  in  use  by  the  Member  States  and  that  have  been  registered  under 
REACH. Member States’ forecasts were used to estimate the flux of incoming applications/dossiers. 
The key tasks involve examination of the applications/dossiers, opinion development and decision 
process. The estimated resources for the initial setup, ICT process infrastructure and development of 
methodologies, for the process from national lists to the first EU positive lists as well as the resources 
involved in other tasks such as helpdesk, legal support are task driven regardless of the number of 
dossiers. 

Once the routine phase for dealing with the tasks under the proposed recast of the Directive has been 
approached  (from  the  tenth  year  onwards),  about  70  %  of  the  resources  will  be  involved  in  the 
operational work (dossier and opinion related efforts).  

Additional limited resources might be necessary for EFSA in case the existing system of FCM (under 
evaluation) is still in place when the review will start (after 2025) to ensure coordination on the review 
of the plastic lists. These potential additional resources are not included in the present estimate. 

Summary of additional resource needs for the drinking water directive regulation: 

Agency 

Summary of tasks 

ECHA 

- Establishing and maintaining four EU 
positive lists for substances and 
compositions authorized to be used for the 
manufacturing of materials in contact with 
water intended for human consumption 

Resource needs 

Financial resource 
needs: 

Human resource 
needs: 

Future budget line: DG Environment 

Candidate for fees: Yes - for authorisations, No - for others 

2021: EUR 1 000 000  
2022: EUR 1 000 000 
2023: EUR 1 000 000 
2024: EUR 510 000 
2025: EUR 520 000 
2026: EUR 530 000 
2027: EUR 540 000 
2021: 3 TA, 2 CA 
2022: 3 TA, 2 CA 
2023: 3 TA, 2 CA 
2024: 3 TA, 2 CA 
2025: 6 TA, 3 CA 
2026: 7 TA, 3 CA 
2027: 8 TA, 3 CA 

63 

 
 
 
 
2.  REGULATION ON SERIOUS CROSS-BORDER THREATS TO HEALTH (2022/2371) 

Responsible body: 

Currently: Commission with the support of the SCHEER Committee 

(Re-)attribution planned to: ECHA, EEA, EFSA, EMA 

Legal basis for reattribution: proposal for regulation on serious cross-border threats to health.  

Type of task: existing 

Brief task overview: ECHA, EEA, EFSA, EMA, ECDC, EMCDDA are tasked, on the request of the 
Commission, to carry out “a risk assessment of the potential severity of the threat to public health, 
including possible public health measures” when there is an alert of a cross-border threat of chemical 
origin (see draft article 20.1(c)). 

Detailed process description:  

Current process: 

Decision 1082/2013/EU on serious cross border threats to health (the Decision) layed down rules on 
combating serious cross border threats to health. Where there is an incident or alert of an actual or 
potential  serious  cross-border  threat  to  health  that  fulfils  the  criteria  detailed  in  Article  9  of  the 
Decision  (Box  1),  the  Commission  shall,  where  necessary  for  the  coordination  of  the  response  at 
Union level and upon request of the Health Security Committee (HSC) or on its own initiative, make 
promptly available to the national competent authorities and to the HSC, through the Early Warning 
Response System (EWRS), a public health risk assessment of the potential severity of the threat to 
public health, including possible public health measures. 

In operational terms, the Commission and the HSC may request the SCHEER to undertake rapid risk 
assessments (within 72h) in case of chemical cross border public health threats from both manmade 
and  naturally  occurring  events  (e.g.  chemicals  released  during  an  incident  or  during  a  volcanic 
eruption) that may have an impact on health (hereafter chemical health threats). The assessment did 
not cover the wider effects on the environment which are outside the scope of addressing the effects 
on  human  health  (e.g.  biological  effects  on  ecosystems)  as  these  were  outside  of  the  remit  of  the 
Decision  and  would  therefore  have  to  be  taken  forward  through  other  existing  mechanisms,  e.g. 
through a separate mandate or different body. 

To implement this obligation, SCHEER has developed a guidance in ad hoc rapid risk assessment of 
serious cross-border chemical health threats. SCHEER set up and maintained a continuous readiness 
to  provide  rapid  risk  assessments  (within  72h)  where  urgently  needed  by  setting  up  a  SCHEER 
permanent working group on rapid risk assessment. The committee held on average 10 meetings per 
year and performed regular crisis exercises.  

Changes in the process: 

The responsibility for rapid risk assessment for risks of a cross-border threat that is linked to medicinal 
products and medical devices is assigned to EMA, for risks of a cross-border threat of chemical origin 
is shared between ECHA and EFSA based on their mandate and for risk of a cross border threat of 
threats of environmental origin, including those due to the climate, are shared among ECHA, EFSA 
and EEA based on their mandate.  

Proximity to Agencies (ECHA, EEA, EFSA and EMA) mandate: EFSA has been already involved 
in  the  rapid  risk  assessment  based  on  the  old  system,  in  parallel  with  SCHEER,  and  thus  have 
developed expertise and procedures. For ECHA and EMA this is a new task. While they have  certain 
expertise in the  area of chemical or environmental risks, they do not have dedicated expertise related 
to risk management of chemical incidents, nor do they hold data on emissions into the environment. 
For EEA is a new task too but EEA holds data on emissions into the environment and there are some 
synergies with (re-)attribution of SEVESO III work on chemical accidents.  

64 

 
 
Projected synergies and added value of reattribution: 

Type 

Synergies 

Reuse of 
capabilities 

Medium 

Process and expertise:  

ECHA, EFSA and EMA already provides scientific advice on chemical 
substances under their mandate. Therefore, the existing capacities on hazard, risk 
and exposure assessment can be reused/reinforced. 

EEA is to be responsible also for SEVESO directive dealing with chemical 
accidents and this expertise can be partly reused.  

Re-use of data 

Medium 

ECHA, EFSA, EMA and EEA can reuse of data collected under other legislation 
within their mandate. 

Workload 
balancing 

Medium 

With only sporadic requests for advice, the workload of Agency experts can be 
balanced. 

IT tools: 
automation and 
economies of 
scale 

Support services: 
economies of 
scale 

Medium 

Not an IT-intensive process, but reuse of IT capabilities for case management, 
interaction with Member States and external experts. 

Medium 

Reuse of scientific support services (e.g. data management and coordination with 
Member States and external experts). Reuse of administrative services. 

Type 

Added value 

Scientific 
consistency 

Medium 

Opportunity to align process and methodology with other related legislation to 
improve coherence in the scientific advice provided to the Commission. Reuse of 
data collected under other legislation. 

Robustness of 
assessment and 
acceptance 

Medium 

Centralising scientific work from dispersed Commission services and 
committees to EU Agencies and their experts.  

Independence 

Medium 

Agencies are independent of the Commission and their experts have to fulfil 
strict non-conflict rules. 

Transparency 

Medium 

Agencies involvement will bring additional transparency to the process: 

-  Overall process transparency 
-  Dissemination of opinions and outcomes 

Main  risks  and  opportunities:  It  might  be  challenging  for  Agencies  to  set  up  and  maintain  a 
continuous readiness to provide rapid risk assessments (within 72h) where urgently needed, similar 
to  what  is  currently  available  through  the  DG  SANTE  secretariat  and  members  of  the  SCHEER 
committee.  

Projected impact on Agencies (ECHA, EFSA, EMA, EEA): 

•  Agencies Committees/bodies: no impact. The task does not require involvement of ECHA 

Committees/bodies 

•  Agencies data model and IT infrastructure: no impact. The task does not require adjustment 

of data structures and IT systems 

•  Agencies key experts: medium impact. The task partly relies on expert competencies that 

65 

 
 
 
are currently not present within the Agencies and will therefore need to be acquired and 
developed 

Workload and resource implications:  

Current workload and resource use 

DG SANTE Health Security unit leads this process (resources spent unknown), but the main work is 
carried out by the SCHEER Committee dedicated working group (on average 10 meetings / year + 
regular crisis exercises, etc.). With this level of activity this work is estimated to take up at least 20% 
of the work time of the DG SANTE SCHEER secretariat (= ca. 0.6 FTE/year) and require significant 
time  from  the  SCHEER  members.  In  addition,  the  operational  budget  for  the  reimbursement  of 
members is at least EUR 48 000 (20% of EUR 240 000/year)  

DG SANTE (Health Security unit) 
DG SANTE (SCHEER secretariat)  

Total 

Current budget line: DG SANTE 

Future workload and resource needs: 

Ca. 0.6 FTE (ca. 20% of SCHEER capacity) 
EUR  48  000  operational  SCHEER  budget  (at 
peak EUR 68 000) 
Ca. 0.6 FTE 

The work performed by SCHEER will be shared among several agencies based on their expertise and 
mandate. The requests for rapid risk assessments are made on ad hoc basis and are not very frequent. 
Considering the existing expertise in the agencies, the existing network of experts, low abundancy of 
the requests, it is expected that the Agencies can absorb the tasks without additional resources.  

Summary of additional resource needs for the regulation on cross-border threats to health: 

Agency 

Summary of tasks 

- contribution to the public health risk 
assessment 

ECHA, 
EEA, EFSA, 
EMA, 
ECDC, 
EMCDDA 

Future budget line: None – no resources allocated 

Candidate for fees: No 

Resource needs 

Financial resource 
needs: 

Human resource 
needs: 

2024: EUR 0 
2025: EUR 0 
2026: EUR 0 
2027: EUR 0 
2024: 0 FTE 
2025: 0 FTE 
2026: 0 FTE 
2027: 0 FTE 

3.  EUROPEAN PARTNERSHIP FOR THE ASSESSMENT OF RISKS FROM CHEMICALS (PARC) 

Responsible body: 

Currently: N/A, no current process exists at EU level 

(Re-)attribution planned to: ECHA, EEA, EFSA  

Legal  basis for reattribution:  None, voluntary (ECHA and EFSA) or grant  (EEA) agreement  to 
participate in the project 

Type of task: new 

Brief task overview: Participate in and provide input and support to the European Partnership for 
the Assessment of Risks from Chemicals 

66 

 
 
 
 
 
 
Detailed process description:  

PARC  is  one  of  the  projects  selected  for  funding  by  the  European  Union’s  "Horizon  Europe" 
framework programme for the 2021-2027 period. It is a 7-year partnership that started on 1st May 
2022 and that consists of 200 partners in 28 countries and at EU level, national agencies and research 
organisations  working  in  the  areas  of  the  environment  or  public  health,  the  European  Chemical 
Agency  (ECHA),  the  European  Food  Safety  Authority  (EFSA)  and  the  European  Environment 
Agency (EEA). 

PARC aims to advance research, share knowledge and improve skills in chemical risk assessment. 
By doing so, it will help support the European Union's Chemicals Strategy for Sustainability, paving 
the way for the "zero pollution" ambition announced in the European Green Deal. 

PARC represents a campaign of unprecedented scale, since it brings together about 200 European 
players, involving national and European health and safety agencies as well as research organisations. 
The partnership encompasses all aspects of chemical risk assessment, aiming in particular to: better 
anticipate  emerging  risks,  better  account  for  combined  risks,  and  underpin  the  concrete 
implementation  of  new  orientations  in  European  public  policies  to  safeguard  health  and  the 
environment in response to important issues for health, the ecology and citizens' expectations. 

The  partnership  builds  on  work  undertaken  as  part  of  the  European  Joint  Programme  on  human 
biomonitoring, HBM4EU (Human Biomonitoring for Europe), which came to an end in the summer 
of 2022, and broadens the scope of its interests specifically to the assessment of environmental risks. 

Main objectives of the PARC are:  

•  Develop the scientific skills needed to address current and future challenges in chemical safety 
•  Provide  new  data,  methods  and  innovative  tools  to  those  responsible  for  assessing  and 

managing the risks of chemical exposure 

•  Strengthen the networks which bring together actors specialised in the different scientific fields 

contributing to risk assessment 

The EU Agencies (ECHA, EFSA and EEA) are to contribute to, participate in and support various 
workpackages of PARC.  

Proximity to mandate: The task is close to EEA, EFSA and ECHA mandate and key competences 
regarding risk assessment of chemicals, management and interpretation of data related to chemicals. 

Projected synergies and added value of (re-)attribution: PARC consortium will benefit greatly 
from invlovement of EU Agencies that hold experience in performing regulatory risk assessment and 
hold knowledge and data for such assessments. Through their experience they can identify gaps and 
needs requiring scientific development and steer such development in a direction that provides the 
highest value for the regulatory risk assessment. The EU Agencies will benefit from the participation 
as  well.  They  can  uptake  immediately  in  the  regulatory  risk  assessment  any  innovation  in  risk 
assessment that PARC will deliver.  

Projected impact on Agencies: 

•  Committees/bodies: no impact. The task does not require involvement of Agencies’ 

Committees/bodies 

•  Data model and IT infrastructure: no impact. The task does not require any new data 

structures and IT systems/capabilities 

•  Key experts: medium impact. The task will require experts in the field to participate in the 

projects. 

Projected workload and resource implications:  

Future workload and resource needs: 

67 

 
 
ECHA participates fully in the project (i.e. as a signatory of the consortium agreement) but without 
(co-)financing  from  the  foreseen  Horizon  Europe  subsidy  to  PARC  and  without  requesting  an 
increase of its EU contribution. To compensate for the workload that PARC will generate, ECHA 
will increase its allocation of Contract Agents by two and will finance them from economies of scale 
and  efficiency  gains.  This  solution  will  be  temporary  until  the  Commission  revises  the  founding 
regulation of ECHA. This revision will be an opportunity to adjust and clarify the future mandate of 
ECHA in the light of the existing and new tasks and assess its resources needs. The role of ECHA in 
the research projects under Horizon Europe will also be clarified in the proposal. 

EFSA participates fully in the project (i.e. as a signatory of the consortium agreement) but without 
(co-)financing  from  the  foreseen  Horizon  Europe  subsidy  to  PARC  and  without  requesting  an 
increase  of  its  EU  contribution.  EFSA  has  dedicated  resources  for  involvement  and  follow  up  of 
relevant EU funded research projects. 

EEA participates fully in the project with (co-)financing from the Horizon Europe subsidy to PARC. 
EEA will finance from the subsidy 2 additional FTEs (2 CAs).  

Summary of additional resource needs for PARC:  

Agency 

Summary of tasks 

EEA 

ECHA 

EFSA 

Resource needs 

Financial resource 
needs: 

Human resource 
needs: 

Financial resource 
needs: 

Human resource 
needs: 

Financial resource 
needs: 

Human resource 
needs: 

2022: EUR 289 000 
2023: EUR 289 000 
2024: EUR 289 000 
2025: EUR 289 000 
2026: EUR 289 000 
2027: EUR 0 
2022: 2 CA 
2023: 2 CA 
2024: 2 CA 
2025: 2 CA 
2026: 2 CA 
2027: 0 CA 
2022: EUR 0 
2023: EUR 0 
2024: EUR 0 
2025: EUR 0 
2026: EUR 0 
2027: EUR 0 
2022: 2 CA 
2023: 2 CA 
2024: 2 CA 
2025: 2 CA 
2026: 2 CA 
2027: 0 CA 
2022: EUR 0 
2023: EUR 0 
2024: EUR 0 
2025: EUR 0 
2026: EUR 0 
2027: EUR 0 
2022: 0 TA, 0 CA 
2023: 0 TA, 0 CA 
2024: 0 TA, 0 CA 
2025: 0 TA, 0 CA 
2026: 0 TA, 0 CA 
2027: 0 TA, 0 CA 

Future budget line: DG Environment, DG GROW, DG RTD  

Candidate for fees: No 

68 

 
 
 
 
 
 
4.  COMMISSION IMPLEMENTING DECISION 2022/1979 UNDER SEVESO DIRECTIVE  

Responsible body: 

Currently: Commission (DG JRC) 

(Re-)attribution planned to: EEA  

Legal basis for reattribution: Commission Implementing Decision 

Type of task: existing tasks plus some improvements 

Brief  task  overview:  Redevelopment  of  databases  (eMARS  and  eSPIRS)  by  the  EEA  for  the 
reporting of information on industrial  major accidents  and for reporting  of the location of Seveso 
establishments. It will integrate some improvements in the reporting format, the workflow and the set 
of reporting tools. 

Detailed process description: The process is described in detail below in the section on projected 
workload 

Proximity  to  mandate:  The  task  is  close  to  EEA  key  competence  on  receiving  and  processing 
reporting information. The agency has the IT and networking infrastructure that is similar to the tasks, 
such as operation of the European pollutant release and transfer register, reporting under the industrial 
emission directive, the F-gas regulation or ozone depleting substances regulation.  

Projected synergies and added value of (re-)attribution: 

Main risks and opportunities:  

Projected impact on EEA: 

•  EEA Committees/bodies: no impact. The task does not require involvement of EEA 

Committees/bodies 

•  EEA data model and IT infrastructure: high impact. The task requires investment in a new 

data structures and IT systems/capabilities 

•  EEA key experts: high impact. The task will require a new dedicated expertise  

Projected workload and resource implications  

Current workload and resource use: 

The development and operation of databases (eMARS and eSPIRS) for the reporting of information 
on industrial major accidents and for reporting of the location of Seveso establishments and providing 
supporting services was performed by DG JRC. The work was performed by 4 FTEs, 1 FTE was an 
official of DG JRC, and 3 FTEs were external consultants.  

Current budget line: DG JRC (core staff) + DG Environment (contractual support) 

Future workload and resource needs: 

A/ During the redevelopment phase of eSPIRS and eMARS (2023-2025) 

IT infrastruture 

One-off cost:  

-  EUR 275 000 and then EUR 200 000 are reserved for the two first years to set up the IT 
eSPIRS systems and the support of Member States to facilitate their reporting within the new 
platform, which will be developed by the EEA.  

69 

 
 
 
-  EUR 60 000 is reserved for the two first years to set up the IT eMARS systems. This amount 
is lower compared to eSPIRS because some tasks will be mutualised between eSPIRS and 
eMARS.  

Yearly cost: 

-  From 2024, the running costs of the two databases require 70 000 EUR per year (hosting of 
tools, maintenance of software, infrastructure and support for the quality assurance of data 
deliveries).  

Staff, 4 agents are needed for the period 2023-2025 for the following roles: 

-  2 IT staff agents : thanks to the mutualisation of tasks related to the IT deployment, continuous 
improvment and support to Member States for the the future eSPIRS and eMARS databases, the 
need of staff is limited to: one full-time equivalent temporary agent (AD TA) (average cost EUR 
199  576/year)  and  one  full-time  equivalent  contract  agent  staff  (CA)  (average  cost  EUR 
107 666/year) at the EEA: 

o  1  AD  TA“IT  expert  –  database  systems  redevelopment”.  Objective:  to  support  the 
implementation of the new IT information system necessary for the eSPIRS and eMARS 
reporting:  

▪ 

IT  project  management  of  the  redevelopment  of  new  tools  and  reporting  system, 
ensuring  design  of  alignment  and  complementarity  with  the  existing  EEA  software 
used for the reporting of industrial information to the EU Registry on Industrial Sites. 
As part of the redevelopment and implementation of the new tools, the agent will lead 
on the following: 

•  Update the data model. This consists in the design and proposal of UML model, 

feature descriptions and deployment and updating the code lists. 

•  Support on updating the technical guidance. 

• 

Integration  of  the  data  model  changes  across  the  reporting  infrastracture.  This 
includes, among others: 
o  Update of the XML schema and EEA dictionary: the existing schemas and 
code  lists  in  the  EEA  data  dictionary  have  to  be  updated  according  to  the 
agreed data model version. 

o  Update of Quality Assurance (QA) scripts: with support from Member State 
Competentent Authorities, stakeholders and thematic experts (see below), the 
agent  will  assess  the  need  of  new  automated  Quality  Assurance/Quality 
Control  (QA/QC)  in  view  of  the  newly  included  reporting  requirements. 
Should this be required, the agent will also integrate these in the reporting 
infrastructure.  Changes  in  the  logic  of  the  data  model  may  also  need 
adjustments of existing QA/QC.  

o  Update of conversion services: this refers to a service of converting an user-
friendly template into EU Registry-compliant XML reports. This service will 
need to be updated.  

o  Update  of  harvesting  routines:  this  relates  to  updating  the  systems  used  to 
incorporate the data reported by Member States into the EEA databases. 

o  Support for the update of the manual for reporters. 

•  Design and run tests for the future reporting tools.  

•  Launch  and  if  necessary  revise/adjust  reporting  tools:  according  to  experience 
with the design and deployment of the EU Registry of indutrial sites, a period of 
around two reporting cycles is needed for all countries to fully succeed in sending 
high-quality  data.  The  IT  speecialist’s  role  will  be  to  incorporate  possible 
70 

 
 
 
changes/adjustments  to  the  reporting  tools  if  necessary,  as  well  as  provide 
technical support to possible IT queries from Member States. It is expected that 
these  will  be  more  numerous  and  complex  during  this  early  period  and  will 
stabilise once all systems are in place.  

•  Adjustment of public-facing products (IT): 

o  Generation of EU datasets. 
o  European Industrial Emissions Portal. 

•  Whereas the data currently reported to eSPIRS could be integrated in the existing 
IT  infrastructure  (with  the  required  changes  outlined  above),  it  is  possible  that 
eMARS will require its own database/IT infrastructure. This is mainly related to 
the  nature  of  the  data  currently  reported  to  eMARS  and  the  specific  legal 
requirements related to the rapid reporting of industrial accidents. The agent will 
evaluate the possible options and work on the design and development of such 
dedicated IT environment if necessary, as well as contribute to the development 
of its support documentation (e.g. manuals, guidance). Also, the agent will provide 
their IT expertise in the process of amending Commission Implementing Decision 
(CID) 2014/895/EU establishing the format for communicating the information 
referred  to  in  Article  21(3)  of  Directive  2012/18/EU  (i.e.  implementing  the 
reporting of accidents, i.e. the eMARS dataflow). This will ensure the language 
and structure of the Decision are suitable, clear and compatible with the fture IT 
requirements.   

▪  Performing the internal EEA function of “data custodian” involving the maintenance 
of  databases,  developing  and  updating  automated  quality  assurance  scripts,  data 
harvesting  scripts  and  IT  dimensions  of  updating  the  website  European  Industrial 
Emission Portal. 

▪  Ensuring that confidentiality, data protection and IT security protocols are maintained 
to the standards required by the EU Institutions, from the design phase throughout the 
pre-operational and operational phases. 

▪  Ensuring  a  secure  access  and  use  of  the  data  that  are  marked  as  confidential,  in 
accordance  with  Article  4  of  Directive  2003/4/EC49.  These  data  shall  neither  be 
publically available nor accessible (directly or indirectly).  

o  1 CA “Member State and stakeholder support”. Objective: to support the transition to 

the future tools with the following tasks: 

▪  Support to the development of the technical guidance for reporters. This support will 
focus  on  coordinating  the  stakeholder  validation  of  the  technical  materials  by  the 
reporters’ community and incorporate their feedback in the materials. The agent will 
engage  with  the  current  community  of  Seveso  reporters  and  will  also  coordinate 
contacts with EU registry reporters, who will also be affected by the changes and who 
will have to liaise with their colleagues reporting on Seveso for the submission of data. 
The agent’s role early on in the process is crucial for ensuring that the system is fit for 
purpose and incorporates the realities of all EU Member States.  

▪  Support  on  Member  State  validation  of  new  automated  QA/QC  checks  and  on 

obtaining feedback during the necessary testing phase/s for the tools. 

▪  Support on Member State validation of manual for reporters.  

49 Directive 2003/4/EC of the European Parliament and of the Council of 28 January 2003 on public access to 
environmental information 

71 

 
 
 
 
▪  From a strategic point of view and in view of the experience with the EU Registry, 
building  the  foundation  of  a  efficient  relationship  with  the  Seveso  community  of 
reporters requires time. Starting this at the development phase is also relevant for a 
smooth  run  of  the  process  once  implemented  and  ensures  dedicated  support  and 
validation to minimise the risk of unnecessary changes and issues later in the process.  

-  2 thematic staff agents for for eSPIRS and eMARS: 2 full-time equivalent temporary agents 
(AD TA) at the EEA (average cost EUR 199 576/year) for the thematic and analytic tasks linked 
to eSPIRS and eMARS: 

o  1 AD TA “Subject matter expert  –  eSPIRS  Seveso  reporting”. Objective:  to  lead the 
EEA activities relating to eSPIRS reporting redevelopment and ensure close links with other 
EEA activities on zero pollution and reporting streams under environment law on industrial 
emissions. It will fulfill the following tasks: 

▪  Supervising  the  redevelopment  of  the  eSPIRS  reporting  tools  by  providing  the 
necessary thematic (expert) perspective. Among others, the agent will ensure that the 
changes  to  the  data  model  and  XML  schema  are  compliant  with  the  reporting 
requirements and are fit for purpose, design and test automated and manual QA that is 
suitable for this dataflow, lead the update of the technical guidance and manual for 
reporters, and interpretation of the legal requirements for their implementation into the 
data model, with support with IT expert and Member State support expert (see above).  
▪  Capacity building and support to the reporters in countries to define the requirements 
of the new eSPIRS reporting tools, train them in their use and assist the interpretation 
of the requirements.  

▪  During the redevelopment phase, liaising with the European Commission services to 
support Member States when designing their reporting systems and tools, including 
agreeing  ad-hoc  adjustments  relevant  to  each  Member  State  legal  and  operational 
frameworks.  

▪  During the redevelopment phase, liasing with the JRC as necessary on historical issues 

and topics that may be of relevance for the new tools.  

▪  Work is ongoing for the design of the Zero Pollution monitoring indicators framework 
and indicators for the Chemicals Strategy for Sustainability. The agent will participate 
in the process to assess how this dataflow can support and design possible indicators. 
▪  Work is ongoing for the design of the Zero Pollution monitoring indicators framework 
and indicators for the Chemicals Strategy for Sustainability. The agent will participate 
in the process to assess how this dataflow can support and design possible indicators. 

▪  Adjustment of public-facing products (thematic perspective): 

•  Generation of EU datasets. 
•  European Industrial Emissions Portal. 

o  1 AD TA “Subject matter expert  – eMARS Seveso reporting”. Objective: to lead the 
EEA activities relating to eMARS reporting redevelopment and ensure close links with other 
EEA activities on zero pollution and reporting streams under environment law on industrial 
emissions. It will fulfill the following tasks: 

▪  Supervising the redevelopment of reporting tools by providing the necessary thematic 
(expert) perspective. Among others, the agent will ensure that the changes to the data 
model  and  XML  schema  (or  design  of  new  IT  tool  if  necessary)  comply  with  the 
reporting requirements and are fit for purpose, design and test automated and manual 
QA that is  suitable for this  dataflow, lead the update of the technical  guidance  and 
manual for reporters, including the interpretation of the legal requirements for their 
implementation into the data model, with support with IT expert and Member State 
support expert (see above).  

72 

 
 
 
▪  CID  2014/895/EU  would  most  likely  need  amendments  and  adapting  to  either  the 
existing  IT  infrastructure  or  a  tailored  infrastructure  compliant  with  the  INSPIRE 
Directive  and  other  requirements  on  data  quality,  security  and  transparency.  The 
thematic  expert  will  support  the  Commission  in  the  identification  of  current  and 
possible future requirements to design the data structure required in the future tools. 
The expert will also assist the Commission during the adoption of the proposed legal 
act through Committee deliberation. To ensure that the outcome is workable for the 
EEA,  the  expert  will  be  involved  as  observer  throughout  the  process  to  advise  on 
consequences of the potential changes that the comitology process may bring. 

▪  During  the  redevelopment  phase  and  beyond,  capacity  building  and  support  to  the 
reporters in countries to define the requirements of the tools, train them in their use 
and assist the interpretation of the requirements.  

▪  During the redevelopment phase, liaising with the European Commission services to 
support Member States when designing their reporting systems and tools, including 
agreeing ad-hoc adjustments relevant to each Member State’s reality.  

▪  During the redevelopment phase, liasing with the JRC as necessary on historical issues 

and topics that may be of relevance for the new tools.  

▪  Work is ongoing for the design of the Zero Pollution monitoring indicators framework 
and indicators for the Chemicals Strategy for Sustainability. The agent will participate 
in the process to assess how this dataflow can support and design possible indicators. 

▪  Adjustment of public-facing products (thematic perspective): 

•  Generation of EU datasets. 
•  European Industrial Emissions Portal. 

▪  To ensure confidentiality, personal data protection and IT security standards are met 
given the sensitive character of these information exchanges and thus keeping systems 
at a state-of-the art level. 

▪  To  ensure  a  secure  access  and  use  of  the  data  that  are  marked  as  confidential,  in 
accordance  with  Article  4  of  Directive  2003/4/EC50.  These  data  shall  neither  be 
publically available nor accessible (directly or indirectly).  

B/ After the redevelopment phase of eSPIRS and eMARS (2026 and beyond) 

IT Infrastructure 

Yearly cost: 

-  The  running  costs  of  the  two  databases  require  70  000  EUR  per  year  (hosting  of  tools, 
maintenance of software, infrastructure and support for the quality assurance of data deliveries).  

Staff, 4 agents are needed from 2026 for the following roles: 

- 

IT staff agents : thanks to the mutualisation of tasks related to the IT deployment, continuous 
improvment and support to Member States for the the future eSPIRS and eMARS databases, the 
need of staff is limited to one full-time equivalent temporary agent (AD TA) (average cost EUR 
199  576/year)  and  one  full-time  equivalent  contract  agent  staff  (CA)  (average  cost  EUR 
107 666/year) at the EEA:  
o  1 AD TA“IT expert – database systems development and maintenance ”. Objective: to 
support the implementation of short-term IT development priorities and long-term system 
maintenance. The agent will address all aspects relating to the IT dimensions of the reporting 

50 Directive 2003/4/EC of the European Parliament and of the Council of 28 January 2003 on public access to 
environmental information 

73 

 
 
 
 
 
 
flows and the storage and use of the databases generated by this exchange of information 
between Member States and the EEA: 
▪ 

IT  support  to  Member  States  following  the  redevelopment  phase:  According  to 
experience with the design and deployment of the EU registry of indutrial sites, a period 
of around two reporting cycles is needed for all countries to fully succeed in sending 
high-quality  data.  The  IT  speecialist’s  role  will  be  to  incorporate  possible 
changes/adjustments  to  the  reporting  tools  if  necessary,  as  well  as  provide  technical 
support to possible IT queries from Member States.  
IT project management of improved tools and reporting system, ensuring alignment and 
complentarity  with  the  existing  EEA  software  used  for  the  reporting  of  industrial 
information  to  the  EU  Registry  on  Industrial  Sites.  As  part  of  the  development  and 
implementation of improvmements, the agent will lead on the following: 

▪ 

• 
Identify improvements. 
•  Update the data model.  
•  Support on update of the technical guidance. 
• 
•  Support for the update of the manual for reporters. 
•  Design and run tests for the future reporting tools.  
•  Possible revisions/adjustments to the improved reporting tools.  

Integrate the improved data model across the reporting infrastracture.  

▪  Performing the internal EEA function of “data custodian” involving the maintenance of 
databases, developing and updating automated QA scripts, data harvesting scripts and 
IT dimensions of updating the website European Industrial Emission Portal. 

▪  Ensuring that confidentiality, data protection and IT security protocols are maintained 

to the standards required by the EU Institutions. 

▪  Ensuring  a  secure  access  and  use  of  the  data  that  are  marked  as  confidential,  in 
accordance  with  Article  4  of  Directive  2003/4/EC51.  These  data  shall  neither  be 
publically available nor accessible (directly or indirectly).  

o  1 CA “Member State and stakeholder support”. Objective: to support Member States on 
the day-to-day proceedings of data submission, quality checking of systematic aspects and 
validation of submissions and other assitance functions to reporters and the general public. 
The agent would achieve the following tasks: 
▪  Performing the Seveso helpdesk function to assist Member States in their reporting.  
▪  Complement automated quality checks by also manually checking reports before their 

harvesting into the master database to systematically ensure basic data quality. 

▪  Production  of  extracts  and  basic  database  analysis  upon  demand  by  the  European 

Commission’s services, the Member States and other stakeholders. 

▪  Assistance  to  feeding  content  from  Seveso  eSPIRS  into  the  European  Industrial 

Emission Portal through its Content Management System (CMS).  

▪  Supporting  publications  and  strategic  communication,  dissemination  and  outreach 

activities (webinars, web visibility) on its practical/technical aspects. 

-  Thematic staff agents for for eSPIRS and eMARS: 2 full-time equivalent temporary agents 
(AD TA) at the EEA (average cost EUR 199 576/year) for the thematic and analytic tasks linked 
to eSPIRS and eMARS: 

51 Directive 2003/4/EC of the European Parliament and of the Council of 28 January 2003 on public access to 
environmental information 

74 

 
 
 
 
 
 
o  1 AD TA “Subject matter expert  –  eSPIRS  Seveso  reporting”. Objective:  to  lead the 
EEA activities relating to eSPIRS  and ensure close links with other EEA activities on zero 
pollution and reporting streams under environment law on industrial emissions. It will fulfill 
the following tasks: 
▪  Overall coordination for the eSPIRS dataflow between Member States (function defined 
at the EEA as “reporters”) and the EEA (function defined in EEA as “data steward”). 
These duties include:  

•  Supervising the development of improvement on the eSPIRS reporting tools by 

providing the necessary thematic (expert) perspective.  
•  Capacity building and support to the reporters in countries. 
•  Quality assuring reports from countries.  

▪  Analysing country data and the resulting European dataset to extract intelligence on the 
distribution of establishments relevant in terms of industrial accidents, cross-checking 
those  with  other  aspects  of  industrial  activities  regulated  by  EU  law  (e.g.  Industrial 
Emission Directive, greenhouse gas emission trading scheme).  

▪  Contributing to the dissemination of the reported information in the European Industrial 
Emission Portal, and ensuring relevant information is also used for assessment activities 
in line with the Agency’s support to the European Commission on Zero Pollution.  
▪  Liaising  with  the  European  Commission  services  and  the  Expert  Groups  and 

Committees relevant to the Seveso Directive. 

▪  Attending  scientific  meetings  related  to  the  subject  matter  and  other  networking 
activities that can contribute to the uptake and use of the reported information in relevant 
Fora.  

o  1 AD TA “Subject matter expert – eMARS Seveso reporting”. Objective: to lead the 
EEA activities relating to eMARS and ensure close links with other EEA activities on zero 
pollution and reporting streams under environment law on industrial emissions. It will fulfill 
the following tasks: 
▪  Overall  coordination  for  the  eMARS  dataflow  between  Member  States  (function 
defined at EEA as “reporters”), the JRC and the EEA (function defined in EEA as “data 
steward”). These duties include: 

•  Supervising the development of improvement on the eMARS reporting tools by 

providing the necessary thematic (expert) perspective.  

•  Capacity  building  and  support  to  the  reporters  in  countries  to  define  the 
requirements  of  the  improved  tools,  train  them  in  their  use  and  assist  the 
interpretation of the requirements.  
•  Quality assuring reports from countries.  

▪  Analysing country data and the resulting European dataset to extract intelligence and 
lessons learned on industrial accidents covered by the Seveso Directive, cross-checking 
those  with  other  aspects  of  industrial  activities  regulated  by  EU  law  (e.g.  Industrial 
Emission Directive, greenhouse gas emission trading scheme) . 

▪  To follow up on reported accidents throught the life cycle of their cases, improving the 

information stored in the database until the conclusion of the case. 

▪  To ensure confidentiality,  personal  data protection and  IT security standards are met 
given the sensitive character of these information exchanges and thus keeping systems 
at a state-of-the art level. 

75 

 
 
▪  To  ensure  a  secure  access  and  use  of  the  data  that  are  marked  as  confidential,  in 
accordance  with  Article  4  of  Directive  2003/4/EC52.  These  data  shall  neither  be 
publically available nor accessible (directly or indirectly).  

▪  Contributing to the dissemination of the reported information in the European Industrial 
Emission Portal, and ensuring relevant information is also used for assessment activities 
in line with the Agency’s support to the European Commission on Zero Pollution.  
▪  Liaising  with  the  European  Commission  services  and  the  Expert  Groups  and 

Committees relevant to the Seveso Directive. 

▪  Attending  scientific  meetings  related  to  the  subject  matter  and  other  networking 
activities that can contribute to the uptake and use of the reported information in relevant 
Fora.  

Summary of additional resource needs for the Commission implementing decision (EU) 2022/1979 
under the SEVESO directive: 

Agency 

Summary of tasks 

Resource needs 

EEA 

Operation of database of industrial plants 
falling under the scope of Seveso III 
Directive 

Operation of database of industrial major 
accidents 

Financial resource needs: 

Human resource needs: 

2023: EUR 335 000 
2024: EUR 330 000 
2025: EUR 70 000 
2026: EUR 70 000 
2027: EUR 70 000 
2023: 3 TA, 1 CA 
2024: 3 TA, 1 CA 
2025: 3 TA, 1 CA 
2026: 3 TA, 1 CA 
2027: 3 TA, 1 CA 

Future budget line: DG Environment  

Candidate for fees: No 

5.  BATTERIES REGULATION (PROPOSAL) 

Responsible body: 

Currently: N/A, no current process for hazardous substances 

(Re-)attribution planned to: ECHA 

Legal basis for reattribution: proposal for a Battery Regulation (revision of Battery Directive). 

Type of task: New 

Brief task overview: Under the proposal for a new Batteries Regulation, a task to prepare, on the 
request  of the Commission,  a restriction  dossiers for substances in  batteries and for the RAC and 
SEAC committees to provide an opinion would be given to ECHA. In addition, ECHA would prepare 
a  mapping  study  by  31/12/2026  on  substances  of  concern  present  in  batteries  or  used  in  their 
manufacturing, in order to assist the Commission to prepare such report to the European Parliament 
and Council by 31/12/2027.  

Detailed process description: 

Current process:  

N/A, no process exists at EU level 

52 Directive 2003/4/EC of the European Parliament and of the Council of 28 January 2003 on public access to 
environmental information 

76 

 
 
 
 
 
New process: 

1.  If the Commission considers that the use of a substance in the manufacture of batteries, or the 
presence  of  a  substance  in  the  batteries  when  they  are  placed  on  the  market,  or  during  their 
subsequent  life  cycle  stages,  including  the  waste  phase,  poses  a  risk  to  human  health  or  the 
environment that is not adequately controlled and needs to be addressed on a Union-wide basis, 
it  shall  request  the  European  Chemicals  Agency  (the  ’Agency’)  to  prepare  a  dossier  that 
conforms  to  the  requirements  of  point  (3)  of  Part  II  of  Annex  XV  to  Regulation  (EC)  No 
1907/2006  (‘restriction  dossier’).  The  restriction  dossier  shall  include  a  socio-economic 
assessment, including an analysis of alternatives.  

2.  The  Agency  shall  publish  without  delay  the  intention  of  the  Commission  to  initiate  such 

restriction process life cycle for a substance, and shall inform stakeholders concerned.  

3.  Within 12 months of the receipt of the request from the Commission in paragraph 1 and if the 
restriction dossier prepared by the Agency pursuant to that paragraph demonstrates that action 
is necessary on a Union-wide basis, the Agency shall suggest restrictions in order to initiate the 
restriction process described in paragraphs 4 to 14.  

4.  The Agency shall make publicly available on its website the restriction dossier, including the 
restrictions  suggested  pursuant  to  paragraph  3,  without  delay,  clearly  indicating  the  date  of 
publication.  The  Agency  shall  invite  all  interested  parties  to  submit  individually  or  jointly, 
within four months of the date of publication, comments on the restriction dossier. 

5.  Within 12 months of the date of publication referred to in paragraph 4, the Committee for Risk 
Assessment (RAC), set up pursuant to Article 76(1)(c) of Regulation (EC) No 1907/2006, shall 
adopt an opinion as to whether the suggested restrictions are appropriate in reducing the risk to 
human health  and/or the environment,  based on  its  consideration of the relevant  parts of the 
restriction  dossier.  This  opinion  shall  take  account  of  the  restriction  dossier  prepared  by  the 
Agency  at  the  request  of  the  Commission,  and  the  views  of  interested  parties  referred  to  in 
paragraph 4. 

6.  Within 15 months of the date of publication referred to in paragraph 4, the Committee for Socio-
economic  Analysis  (SEAC),  set  up  pursuant  to  Article  76(1)(d)  of  Regulation  (EC)  No 
1907/2006, shall adopt an opinion on the suggested restrictions, based on its consideration of 
the relevant parts of the dossier and the socio-economic impact. Prior to that, it shall prepare a 
draft  opinion  on  the  suggested  restrictions  and  on  the  related  socio-economic  impact,  taking 
account of the analyses or information according to paragraph 4, if there are any. 

7.  The Agency shall publish the draft opinion of the Committee for Socio-economic Analysis on 
its website without delay and invite interested parties to provide their comments on the draft 
opinion no later than 60 days from the publication of that draft opinion. 

8.  The Committee for Socio-economic Analysis shall without delay adopt its opinion, taking into 
account where appropriate further comments received by the deadline set in paragraph 7. This 
opinion shall take account of the comments of interested parties submitted under paragraphs 4 
and 7. 

9.  Where  the  opinion  of  the  Committee  for  Risk  Assessment  diverges  significantly  from  the 
restrictions suggested, the Agency shall postpone the deadline for the opinion of the Committee 
for Socio-economic Analysis by a maximum of 90 days. 

10. The Agency shall submit to the Commission without delay the opinions of the Committees for 
Risk  Assessment  and  Socio-economic  Analysis  on  the  restrictions  suggested  pursuant  to  the 
request made by the Commission under paragraph 1. Where the opinions of the Committees for 
Risk  Assessment  and  Socio-economic  Analysis  diverge  significantly  from  the  restrictions 
suggested  pursuant  to  paragraph  3,  the  Agency  shall  submit  an  explanatory  note  to  the 
Commission providing a detailed explanation of the reasons for such differences. If one or both 

77 

 
 
of the Committees do not adopt an opinion by the deadline set in paragraphs 5 and 6 the Agency 
shall inform the Commission accordingly, stating the reasons. 

11. The Agency shall publish the opinions of the two Committees on its website without delay. 

12. The  Agency  shall  provide  the  Commission  on  request  with  all  documents  and  evidence 

submitted to or considered by it. 

13. If the Commission concludes that the conditions laid down in Article 6(2) are fulfilled, it shall 
adopt a delegated act pursuant to Article 6(2). This delegated act shall be adopted without undue 
delay  following  the  receipt  of  the  opinion  of  the  Committee  for  Socio-economic  Analysis 
referred to in paragraph 8 or after the deadline set out under paragraphs 6 and 9, as applicable, 
if that Committee does not adopt an opinion. 

14. Where the Committees for Risk Assessment and Socio-economic Analysis provide an opinion 
pursuant to paragraphs 5 and 6, they shall make use of rapporteurs as specified in Article 87 of 
Regulation (EC) No 1907/2006. The rapporteurs or co-rapporteurs concerned, or their employer, 
shall be remunerated by the Agency in accordance with a scale of fees to be included in the 
financial  arrangements  related  to  restrictions  established  by  the  Management  Board,  set  up 
pursuant to Article 76(1)(a) of Regulation (EC) No 1907/2006. Where the persons concerned 
fail  to  fulfil  their  duties,  the  Executive  Director  of  the  Agency  has  the  right  to  terminate  or 
suspend the contract or withhold remuneration 

Proximity to ECHA mandate: The battery restriction process, although not identical, is very similar 
to  the  REACH  restriction  process  and  the  same  scientific  methodologies  can  be  applied.  The 
substances under scrutiny are the same or similar to those under REACH and REACH (and other 
ECHA)  data  and  processes  can  be  reused  for  battery  restriction  dossier  development  and  opinion 
forming. ECHA holds the right competences to manage the battery restriction process, however, does 
not have sufficient information on the exact use of substances in batteries, which is to be remedied 
with a study to be commissioned.  

Projected synergies and added value of reattribution: 

Type 

Synergy 

Reuse of 
capabilities 

High 

Re-use of 
data 

Medium 

Workload 
balancing 

Medium 

Process and expertise: ECHA already supports similar work 
on substance restrictions under REACH and other 
legislation. Several key capacities can be reused/reinforced: 

-  Hazard, risk, exposure and socio-economic 

assessment 

-  Committee opinion development 
-  Existing IT capabilities for authority dossier 
submission, stakeholder consultation and 
dissemination 

Reuse of substance identification and hazard data collected 
under other chemical legislation. Currently low availability 
of data on substances in products and waste streams. 

With an estimated workload of one new restriction every 
year, the workload of Agency experts and Committee 
experts can be spread and balanced over the years (although 
resource estimates are already annualised). 

IT tools: 
automation 

High 

Reuse of IT capabilities for case management, public 
consultation, interaction with Member States, regulatory 

78 

 
 
and 
economies of 
scale 

Support 
services: 
economies of 
scale 

High 

Type 

Added value 

Scientific 
consistency 

High 

Robustness of 
assessment and 
acceptance 

High 

Independence  High 

intentions management and data dissemination. 

Reuse of scientific support services (e.g. committee 
secretariat, prioritisation and grouping of substances, 
substance identification, data management and 
dissemination). Reuse of administrative services. 

Opportunity to align priority setting, timeline, process and 
methodology with other related legislation to improve 
coherence in the scientific advice provided to the 
Commission. Reuse of assessment insights developed under 
other chemical legislation. 

Centralising the scientific assessments on chemicals in one 
EU agency and stricter separation between policy and 
scientific advice adds more scientific robustness to the 
process. 

ECHA and its committees work under strict conflict of 
interest avoidance rules, improving guarantees of 
independent scientific advice to the Commission. 

Transparency  High 

ECHA’s involvement will bring transparency to the process: 

-  Overall process transparency 
-  Publication of regulatory intentions of EU authorities 
improves predictability for industry stakeholders 

-  Public consultation/call for evidence 
-  Stakeholder involvement/observer status 
-  Dissemination of scientific data and outcomes 

Main  risks  and  opportunities:  No  major  concerns  and  there  are  certainly  opportunities  to  find 
synergies with the REACH restriction process. 

Projected impact on ECHA  

-  ECHA Committees/bodies: medium impact. The task generates medium impact on the setup / 

organisation / staffing of Committees/bodies due to the additional workload. 

RAC 

# of 
opinions 
per year 

1  

rapporteur  Type of 
opinion 

RAC 
member 

SEAC 

# of 
opinions 
per year 

1  

rapporteur  Type of 
opinion 

SEAC 
member  

Restriction 
dossier  

-  ECHA  data  model  and  IT  infrastructure:  low  impact.  The  task  can  be  implemented  with 

adjustments / configuration of existing data structures and IT systems  

79 

 
 
 
 
 
 
 
 
 
 
 
 
-  ECHA key experts: medium impact. The task partly relies on existing expert competencies 
which are limited within ECHA and also critical to REACH/CLP/BPR regulatory tasks 

Projected workload and resource implications:  

Current workload and resource use: 

N/A, no current process exists at EU level 

Future workload and resource needs: 

A total of 2 new full-time equivalent temporary agent staff (AD 5-7) at ECHA (average cost EUR 
171 000/year with coefficient for FI and annual indexation over 4 years and beyond) will be needed 
to make sure that sufficient resources would be earmarked for regulating the necessary battery related 
substances  without  competing  with  REACH  priorities.  This  covers  an  average  of  one  additional 
restriction (or other risk management measure) yearly, including risk assessment of lead in lead-acid 
batteries, and of mercury and cadmium used in electric vehicle batteries.  

In addition, 1 full-time equivalent contract agent staff for 3 years (CA FG III, average cost EUR 91 
000/year with coefficient for FI and annual indexation over 3 years), will be necessary to increase the 
knowledge base and carry out a mapping of substances of concerns used in batteries, facilitating an 
informed priority setting and work plan establishment. This will be based on a mapping study to build 
ECHA’s current knowledge on how the battery industry manages its hazardous chemicals to identify 
relevant substances for regulatory risk management in the future. The study is estimted at EUR 400 
000 (over 3 years) to outsource part of such research needs.  

A sum of EUR 22 000 is also required to cover the cost of the rapporteurs (Member State experts 
guiding  the  dossiers  through  the  opinion-making  in  the  RAC  and  SEAC  committees)  for  each 
restriction, as well as EUR 43 000 over 4 years for covering a proportionate part of the full cost of 
organising  the  RAC  and  SEAC  meetings  (travel,  accommodation  and  daily  allowance  costs:  cost 
calculated based on the average time/effort needed for a restriction dossier in both committees). 

The aforementioned resources have been estimated using a calculation model which takes account of 
relevant experience from tasks executed by ECHA under other regulatory frameworks (e.g. REACH, 
CLP, BPR) and from the implementation of the existing national approaches where relevant. It sets 
out the resources that will be needed by ECHA over 2024-2027 and beyond, in order to handle the 
foreseen tasks. 

Summary of additional resource needs for the batteries regulation: 

Agency 

Summary of tasks 

ECHA 

Assessment underlying the restriction of 
hazardous substances in batteries (1 restriction / 
year)  

-  Substance prioritisation and data 

Resource needs 

Financial resource 
needs: 

analytics 

-  Restriction dossier development 
-  RAC opinion development 
-  SEAC opinion development 
-  Dissemination 

Human resource 
needs: 

Future budget line: DG Environment 

2023: EUR 158 000 
2024: EUR 158 000 
2025: EUR 158 000 
2026: EUR 25 000 
2027: EUR 25 000 
2028: EUR 25 000 

2023: 2 TA, 1 CA 
2024: 2 TA, 1 CA 
2025: 2 TA, 1 CA 
2026: 2 TA, 0 CA 
2027: 2 TA, 0 CA 
2028: 2 TA, 0 CA 

80 

 
 
 
 
 
 
Candidate for funding from fees: No 

6.  E-PRTR REGULATION (2006/166) 

Responsible body : 

Currently: N/A, no current process as it is expansion of the existing task performed by EEA 

(Re-)attribution planned to: EEA 

Legal basis for reattribution: Revision of the EPRTR regulation (166/2006) 

Type of task: new (extension of the existing one) 

Brief task overview: EEA currently operates the European Pollutant Release and Transfer Register. 
The existing EPRTR is replaced by an Industrial Emissions Portal that should be operated by EEA 
too. The new Portal should contain more data and provide more functionalities as compared to the 
old  EPRTR.  The  Portal  should  provide  information  on  emission  for  more  substances,  for  more 
installations and for more activities. It should also provides information on the use of water, energy 
and raw materials by the concerned installations to allow monitoring of progress towards a circular, 
highly resource-efficient economy.  

Proximity to EEA mandate: The operation of the Industrial  Emission Portal  fits  well within  the 
mandate of EEA. EEA already operates the existing EPRTR and the new Portal has evolved from the 
EPRTR.  

Projected synergies and added value of (re-)attribution: 

Type 

Synergies 

Reuse of 
capabilities 

High 

Process and expertise: EEA already operates EPRTR, manages 
reporting flows from installations and Member States and manages 
related environmental information on air quality and water quality. 
Several key capacities can be reused and further developed.  

Re-use of data  High 

Reuse of data collected under other environmental legislation (air 
and water) can be combined.  

IT tools: 
automation 
and economies 
of scale 

Support 
services: 
economies of 
scale 

High 

The existing IT capabilities can be partly reused. 

High 

Reuse of support services for reporting and data management. 
Reuse of administrative services. 

Main risks and opportunities: N/A 

Projected impact on EEA: 

•  EEA Committees/bodies: no impact. The task does not require involvement of EEA 

Committees/bodies 

•  EEA data model and IT infrastructure: high impact. The task requires adjustment of data 

structures and IT systems and their long term operation 

81 

 
 
 
 
•  EEA key experts: low impact. The task can utilise existing expert competences.  

Projected workload and resource implications  

Current workload and resource use: 

N/A, no current process as it is an extension of the existing one. 

Future workload and resource needs: 

EEA  costs  include  cost  of  2  additional  FTE  (2  TAs)  who  will  establish  the  IT  infrastructure  for 
collecting new data fields (on resource use and additional pollutants), modify and expand the XML 
schema  to  enable  reporting  at  installation  level  and  for  newly  captured  agro-industrial  activities, 
update the Manual for Reporters to ensure consistent returns by operators/MS, run training sessions 
for MS reporters to introduce these new requirements, and subsequently manage the reporting and 
related dataflow. Costs of developing IT infrastructure will go down in the 3rd year, as only the IT 
infrastructure maintenance costs will remain. It’s assumed that for the first two years EEA will need 
more financial resources to revamp the existing tools as a result of the legal proposal. 

EEA staff will establish the IT infrastructure that will be required to implement the proposed revisions 
and subsequently manage the reporting and related dataflow. These IT enhancements relate to the 
physical  capacity  of  the  reporting  stream  (i.e.  number  and  nature  of  reports)  and  the  supporting 
systems  (guidance,  training  etc.)  to  ensure  their  consistent  application  by  industrial  operators  and 
Member States. 

Summary of additional resource needs for E-PRTR regulation: 

Agency 

Summary of tasks 

EEA 

•  Establishing and operating the IT 

infrastructure for collecting new data 
fields 

•  Updating the manual for reporters 

•  Run training sessions for MS reporters 

Resource needs 

Operational resource 
needs: 

Human resource 
needs: 

2024: EUR 170 000  
2025: EUR 70 000 
2026: EUR 30 000 
2027: EUR 30 000 
2024:  2 TAs, 0 CA 
2025:  2 TAs, 0 CA 
2026:  2 TAs, 0 CA 
2027:  2 TAs, 0 CA 

Budget line: DG Environment 

Candidate for fees: No 

7. 

INDUSTRIAL EMISSIONS DIRECTIVE (2010/75/EU) 

Responsible body: 

Currently: N/A, no current process 

(Re-)attribution planned to: ECHA 

Legal basis for reattribution: Revision of the Industrial Emissions Directive (2010/75/EU) 

Type of task: new 

Brief  task  overview:  ECHA  has  already  for  some  time  provided  input to  the  Commission  to  the 
review of the Best Available Techniques Reference documents (BREF). Now ECHA's role has been 
formalised as part of this revised proposal. Overall, ECHA’s role would include routine support to 
BREF/BAT and support to design/ implementation of the Chemicals Management System (CMS) 
methodology. 

Detailed process description: 

82 

 
 
 
 
Current process: 

N/A, no process exists at EU level 

New process: 

While ECHA has already done some work in this area, the Commission has now proposed giving 
ECHA a formal role in drawing up BAT reference documents (BREFs).  

The role of ECHA would be to ensure that:  

•  An  appropriate  identification  (and  if  necessary  selection)  of  relevant  substances  for  each 
sector/BREF is made. This will include a characterisation of the uses of those substances by 
sectors covered by BREFs including definition of best practices to use the safest alternatives 
on  the  market.  This  will  improve  clarity  and  consistency  of  the  various  legislations  (IED, 
REACH, CLP)  

•  The correct terminology is used in the BREF processes (e.g. substance, process chemical, raw 

material)  

•  The chemicals-related BATs (such as substitution techniques) are technically sound  

•  Background documents, for Kick off Meeting and final meeting, drafted by the EIPPCB are 

relevant regarding chemicals issue  

•  Assistance is provided to the EIPPCB to access the information on ECHA’s database  

•  Assistance  is  provided  to  answer  stakeholders  questions  or  comments  where  a  chemicals 

expertise is needed 

The Commission would facilitate this work by organising an exchange of information between the 
concerned industries, Member States, NGOs and ECHA. In addition, by 2024, ECHA should start 
building a methodology for on-site risk assessment to actively manage input chemicals and resulting 
emissions. 

In short ECHA's new tasks would include the following: 

•  Data  mining  of  ECHA  databases  and  generating  a  list  of  hazardous  substances  potentially 
used in BREF sectors; extract substance-related information (regulatory status, classification, 
substance identity), characterise the uses of those substances by sectors covered by BREFs 
including definition of best practices to use the safest alternatives on the market, and provide 
technical support to BREF revisions (TWG meetings, review, other technical inputs).  

•  Develop  guiding  principles  for  the  Chemicals  Management  System  focussing  on  data 
structure  and  methodologies  for  a  site  inventory  of  chemicals  (substances  and  mixtures) 
associated  with  further  development  of  a  site-level  risk  assessment  methodology  and 
contribute to  the development of guiding principles on how to  conduct  a comparative risk 
assessment between the substances an operator uses for his processes/products and potential 
alternatives.  

Proximity to ECHA mandate: This new task would mainly be the formalisation of a task already 
performed by ECHA on an ad hoc basis, with the addition of support to design/ implement the CMS 
methodology.  

Projected synergies and added value of reattribution: 

Type 

Synergies 

Reuse of 
capabilities 

High 

Process and expertise: ECHA already provides scientific advice on 
chemical substances and as it has supported related ad hoc advice 
requests in the past, it already has the needed expertise. Several key 

83 

 
 
capacities can be reused/reinforced: 

-  Hazard, risk and exposure assessment 
- 

IT capabilities for stakeholder consultation and 
dissemination 

Re-use of data  High 

Reuse of data collected under other chemical legislation, especially 
also on substances in products via the SCIP database. 

Workload 
balancing 

Medium  With occasional requests, the workload of Agency experts can be 

balanced (although resource estimates are already annualised). 

High 

High 

IT tools: 
automation 
and economies 
of scale 

Support 
services: 
economies of 
scale 

Not an IT-intensive process, but reuse of IT capabilities for case 
management, public consultation, interaction with Member States 
and data dissemination. 

Reuse of scientific support services (e.g. prioritisation and grouping 
of substances, substance identification, data management and 
dissemination). Reuse of administrative services. 

Type 

Added value 

Scientific 
consistency 

High 

Opportunity to align priority setting, timeline, process and 
methodology with other related legislation to improve coherence in 
the scientific advice provided to the Commission. Reuse of data 
collected under other chemical legislation. 

Robustness of 
assessment and 
acceptance 

High 

Centralising scientific work from dispersed Commission services to 
one central EU Agency and its experts.  

Independence  High 

Moving scientific work from dispersed Commission services to 
experts in the European Chemicals Agency with a stricter 
separation between science and policy. ECHA experts work under 
stricter conflict of interest avoidance rules, improving guarantees of 
independent scientific advice to the Commission. 

Transparency  High 

ECHA’s involvement will bring additional transparency to the 
process: 

-  Overall process transparency 
-  Public consultation/call for evidence 
-  Stakeholder involvement 
-  Dissemination of scientific data and outcomes 

Main risks and opportunities: N/A 

Projected impact on ECHA: 

•  ECHA  Committees/bodies:  no  impact.  The  task  does  not  require  involvement  of  ECHA 

Committees/bodies 

84 

 
 
 
 
•  ECHA data model and IT infrastructure: no impact. The task does not require adjustment of 

data structures and IT systems 

•  ECHA key experts: high impact. The task heavily relies on expert competencies, which are 

limited within ECHA and also critical to REACH/CLP/BPR regulatory tasks 

Workload and resource implications:  

Current workload and resource use: 

N/A, no current process 

Future workload and resource needs: 

ECHA costs include cost of new 3 FTEs, who  

•  will  do  the  data  mining  of  ECHA  databases  and  generate  a  list  of  hazardous  substances 
potentially  used  in  BREF  sectors;  extract  substance-related  information  (regulatory  status, 
classification, substance identity), characterise the uses of those substances by sectors covered 
by BREFs including definition of best practices to use the safest alternatives on the market, 
and  provide  technical  support  to  BREF  revisions  (TWG  meetings,  review,  other  technical 
inputs) – 2 FTE  

•  Develop  guiding  principles  for  the  Chemicals  Management  System  focussing  on  data 
structure for a site inventory of chemicals (substances and mixtures) associated with further 
development of a site-level risk assessment methodology and contribute to the development 
of guiding principles on how to conduct a comparative risk assessment between the substances 
an operator uses for his processes/products and potential alternatives - 1 FTE 

In total, 3 TA posts  

Summary of additional resource needs for industrial emissions directive: 

Agency 

ECHA 

Summary of tasks 

•  Mining of ECHA databases and generate a 
list of hazardous substance potentially 
used in BREF; 

•  Extract substance-related information, 

characterise the uses 

•  Technical support to BREF revisions 
•  Develop guiding principles for the 
Chemicals Management System 

•  Contribute to the development of guiding 

principles on how to conduct a 
comparative risk assessment 

Resource needs 

Operational resource 
needs: 

Human resource 
needs: 

2024: EUR 0  
2025: EUR 0 
2026: EUR 0 
2027: EUR 0 
2024: 3 TAs, 0 CA 
2025: 3 TAs, 0 CA 
2026: 3 TAs, 0 CA 
2027: 3 TAs, 0 CA 

Future budget line: DG Environment  

Candidate for fees: No 

8.  ENVIRONMENTAL  QUALITY  STANDARD  DIRECTIVE  (2008/105/EC)  +  WATER  FRAMEWORK 

DIRECTIVE (2000/60/EC) + GROUNDWATER DIRECTIVE (2006/118/EC) 

Responsible body: 

Currently: Commission with the support of the SCHEER committee, JRC and consultants 

(Re-)attribution planned to: ECHA and EEA 

85 

 
 
 
 
Legal basis for reattribution: revision of Environmental Quality Standard Directive (2008/105/EC), 
Ground Water Directive (2006/118/EC) and Water Framework Directive (2000/60/EC) + Omnibus 
regulation. 

Type of task: Existing + new 

Brief task overview 

1.  Assessments  underpinning  amendment  of  priority  list  of  substances  and  derivation  of 

Environmental Quality Standards under EQS Directive; 

2.  New legal task: EU-wide EQS for substances listed in a (new) Annex II of the EQSD including 
the so-called ‘River Basin Specific Pollutants’ (two per year); EU-wide threshold values for 
groundwater pollutants (one per year) to be included in Annex II GWD 

3.  Assessment underpinning review of Annexes I and II of the Groundwater Directive; 

4.  Technical and scientific work related to amendment of ‘watch list’ and coordination of ‘watch 

list’ activities both under EQS and Groundwater Directives. 

Detailed process description: 

Current process 

Summary process description 

Surface water: 

Watchlist and priority list work currently done by JRC and after that a SCHEER opinion. IA of EQS 
proposals for new substances on the Priority Substance (PS) list outsourced to contractor. For future: 
Risk Assessment Committee (RAC) not needed for identification of substances for monitoring (watch 
list). ECHA involvement lighter, but heavier for 6y priority setting, including RAC. 

-  Watch  List:  identifying  new  substances  for  and  removing  substances  from  the  Watch  List 
(amendment  needed  every  2  years  (EQSD Article  8b(2)).  The  Commission  is  considering 
moving to a three-year review cycle) 

o  Proposals  for  adding  and  removing  substances  (including  mixtures):  usually  ca.  10 
substances  /  mixtures  on  watch  list  (based  on  literature  overviews,  information 
resulting from other legislation) 

o  Establishment/identification of the related PNECs. No RAC involvement. 
o  Verification of the suitability and availability of monitoring and analytical methods 
not entailing significant costs, and compilation of information on these for Member 
States;   
Issue is often absence of monitoring methods, otherwise nothing can be monitored. 
ECHA to check availability and suitability of tests. This work we haven’t done much 
in  the  past.  Registrants  have  to  supply  appropriate  analytical  methods  for  their 
substances, follow-up more now. ECHA could run a consultation to identify available 
analytical  methods.  However,  ECHA  does  not  have  the  expertise  to  also  test  their 
suitability, so it would preferably outsource such task to a scientific institute. 

o  Assessment of monitoring results in view of identifying the need for setting EU wide 

or national EQS (based on importance, frequency, impact of exceedances) 

-  Priority List: technical work on reviewing the PS list (six-year review cycle; through delegated 

acts) 

o  Prioritisation work 
o  Establishment  of  EQSs  for  new  (groups  of)  PS  or  trigger  values  for  (effect-based) 

groups of PS 

86 

 
 
o  Development of a final proposal (on new and revised PS/PHS, EQS), supported by an 
opinion  from  the  Risk  Assessment  Committee  (RAC)  and  from  the  Committee  for 
Socio-Economic Assessment 

o  Regular discussion and presentation in the WG Chemicals or related subgroup 

-  New 1 (similar to current task 2 under GWD): EU-wide EQS for substances listed in a (new) 
Annex  II  of  the  EQSD  including  the  so-called  ‘River  Basin  Specific  Pollutants’  (RBSP) 
formerly part of the ‘ecological status’ component of surface water status. The intention is 
that MS will apply the listed EQS (rather than national EQS) if they identify the substances 
as posing a risk; MS will be asked to upload/send these national EQS for uploading in the EU 
wide Repository to be established by ECHA; this will enable ECHA to assist EC in prioritising 
RBSPs for which the largest divergences have been identified without those being justified; 
and develop the EU-wide EQS; the latter would be adopted through delegated acts; timeline: 
one EQS per year, adoption by delegated act every six years. Difference with EU EQS for 
priority substances apply in all cases, i.e. the substances are prioritised because of their overall 
EU concern; for EQS for RBSPs, MS should in principle establish themselves EQS whenever 
an RBSP is of national/local concern; but even for these, where it appears that divergences 
are too wide between MS without this being justified; there is a need to set EU wide EQS, to 
be applied however only when there is a national or local issuer 

-  New 2: identification of suitable monitoring methods for monitoring and analysis of PFAS, 
by  2  years  after  entry  into  force  and  for  microplastics  (2  years)  and  Antimicrobiotical 
resistance genes (AMR) (2 years). 

Groundwater: 

Groundwater: no JRC involvement currently, most work done by Member State expert group and 
contractor and outcome sent to SCHEER 

-  Specific technical work on six-yearly reviewing the pollutants and quality standards in Annex 

I  

-  New: Six yearly review of list of pollutants in Annex II for which MS must consider setting 
national  thresholds  if  there  is  a  local/regional/national  problem  (difference  with  Annex  I 
which relates to pollutants of EU wide concern) 

- 

-  New: develop/identify EU wide threshold values for pollutants currently covered by a national 
threshold  value  (in  Annex  II),  where  necessary  to  ensure  better  and  more  harmonised 
implementation: one per year, threshold values to be adopted by delegated act once every six 
years 
In summary, review of the pollutants listed in the two annexes and of the quality standards in 
Annex  I  and  development  of  EU  wide  threshold  values  for  pollutants  listed  in  Annex  II. 
proposals for the amendment of Annexes I and II, based on scientific and technical evidence; 
Development of proposals for the amendment of Annexes I and II, based on scientific and 
technical  evidence;  Opinion  development  via  the  RAC  and  SEAC  committee;  regular 
presentation and discussion in the WG Groundwater. 

-  New: mandatory Watch List:  

o  Proposals for adding and removing substances 
o  Verification of the suitability and availability of monitoring and analytical methods 

not entailing significant costs, and compilation of information on these for MS 

o  Development of the related PNECs. No RAC involvement 

-  New:  identification of suitable monitoring methods for monitoring and analysis of PFAS, by 
2 years after entry into force and for microplastics (2 years) and Antimicrobiotical resistance 
genes (AMR) [2 years]. 

87 

 
 
 
 
 
Detailed description of current process 

Amendment of the list of priority substances for surface waters and development of Environmental 
Quality  Standards  (EQS), including  designation  of  Priority Hazardous Substances  (from  Water 
Framework  Directive  (2000/60/EC)  and  its  daughter  directive  EQS  Directive  (2008/105/EC)  as 
amended by 2013/39/EU): 

•  The amendment (and associated technical and scientific work) is initiated by the Commission. 
•  Consultant and/or JRC prioritises substances to be included in the list of priority substance (PS-
list) using a combination of monitoring-based approach and modelling-based approach, including 
the results of the watch-list monitoring. Their work is regularly discussed in a sub-group of the 
CIS WG Chemicals known as the Sub-Group on Review (SG-R) of the PS list. The outcome is a 
ranking  of  substances  based  on  their  potential  risks.  (~  REACH  prioritisation  of  candidate 
substances for further risk management) 

•  Consultant and/or JRC reviews the existing PS-list with a view to determine whether some should 
be taken off the PS-list. A document has been drafted identifying potential criteria for removing 
substances, considering that even if existing PS no longer pose a risk, removing them could result 
in them again becoming a risk, unless their use has been banned. 

•  Commission (DG ENV) in consultation with WG Chemicals selects substances for which EQS 
are  derived  and  which  of  the  listed  substances  should  be  designated  as  priority  hazardous 
substances. 

•  Commission (consultants, JRC) or volunteer Member States derive EQS for newly selected PS 
(groups of PS), and review EQS for existing PS if new data are available. The work is organised 
in  subgroups  for  specific  substances,  led  by  the  consultants,  JRC  or  volunteer  Member  State 
experts and are also discussed in WG Chemicals, subject to public open and targeted consultation 
and  specific  technical  workshops  with  experts  under  the  IA  support  contract.  (~derivation 
of/proposal  for  Exposure  Limits)  (~stakeholder  and  public  consultation)  (~Adaptation  to 
Technical Progress) 

•  Commission consults SCHEER on EQS derivation. (~RAC opinions) 
•  Consultants prepare an impact assessment study of listing of a substance in the PS-list. (~Socio-

economic Assessment – SEAC opinion) 

•  Commission makes a proposal for listing the substances in the PS-list and for setting EQS values. 

The proposal goes through the ordinary legislative procedure. 

•  Updated Annexes are published by the Commission. 

Review  and amendment  of the  surface-water watch-list  (from  EQS  Directive  (2008/105/EC)  as 
amended by 2013/39/EU): 

•  The amendment (and associated technical and scientific work) is initiated by the Commission. 
•  Consultant  and/or  JRC  performs  prioritisation  exercise.  EQSD  Article  8b(1)  specifies  the 
information to be taken into account. It is important to have an estimate of the PNEC (~derivation 
of PNEC) and to ensure that an adequately sensitive analytical method is available. 

•  JRC reviews the existing watch-list with a view to taking substances off the list. The substances 
can  only  stay  on  for  up  to  4  years,  but  if  sufficient  high-quality  monitoring  data  are  obtained 
sooner, they should be removed (~hazard assessment?) (~proposal for identification of candidate 
substances). 

•  The review of the watch-list is carried out in consultation with WG Chemicals. 
•  The Commission adopts a new watch-list in the form of an Implementing Act subject to agreement 

in the WFD Regulatory Committee. 

•  Member States performs the monitoring and report data to EEA.  

88 

 
 
 
 
•  JRC analyses the monitoring data whether there is an EU-wide risk. 

Review  of  Annexes  I  and  II  and  Voluntary  groundwater  watch-list  (from  Ground  water  directive 
(2006/118/EC)): 

•  The  amendment  (and  associated  technical  and  scientific  work) is initiated  by  the  Commission 
under  its  legal  obligation (GWD  art.  10).  This  was  initiated  after  the  WFD  fitness  check 
conclusions (2019), but technical works of the watch list started already in 2015. 

•  Commission and CIS WG Groundwater consultant with the technical and scientific support of the 
specific subgroup collects data and prioritises substances to be included in the annexes using an 
agreed methodology (2018). These are included in a ‘List facilitating the review’. (When there 
are  insufficient  monitoring  data,  substances  are  proposed  for  the  voluntary  watch-list). 
Prioritization and selection process involves several steps, and relies upon aggregate data from 
national entities across Europe on substance occurrence in groundwater, as well as available data 
on  substance  persistence,  mobility,  toxicity,  and  bioaccumulation  behaviour.  The  work  is 
regularly shared with CIS WG Chemicals and JRC. 

•  Based on updated monitoring data, the consultant reviews the existing voluntary watch-list and 
list facilitating the review with a view of adding substances to the lists. Outcomes are provided to 
Commission and shared/discussed with WG Groundwater experts. 

•  Commission  proposes  substances  for  potential  inclusion  in  the  two  annexes.  These  are  also 
considered  in  the  Impact  Assessment  (IA)  Support  Study  policy  options  and  corresponding 
economic analysis (consultants). 

•  Commission  (JRC  or  consultant)  propose  potential  quality  standards  for  newly  proposed 
substances for Annex I and II. These are also shared with WG Groundwater experts, subject to 
public open and targeted consultation and specific technical workshop with groundwater experts 
under the IA support contract.   

•  The  Commission  consults  the  SCHEER  on  selection  of  substances  and  the  derivation  of  EU 
quality standards (also consulting whether any of the proposed substances should be considered 
for Annex II, in which case MS are to derive threshold values). 

•  Consultants carry out an impact assessment support study of policy options that consider listing 

substances in Annex I (with EU quality standard) or Annex II. 

•  Commission makes a proposal for listing the substances in Annex I of the Groundwater Directive 
(and EU quality standards if proposed for Annex I) or for adding substances in Annex II. The 
proposal for Annex I goes through the ordinary legislative procedure; the proposal for Annex II 
goes through ‘comitology: regulatory procedure with scrutiny’ (last review took place in 2014). 

•  Updated Annexes are published by the Commission. 

Additional  details  for  the  voluntary  groundwater  watch  list  mechanism  (progresses  and  outcomes 
regularly shared with WG Chemicals and JRC).   

•  Consultant and group of volunteers within CIS WG Groundwater performs prioritisation exercise 

(groups of substances), collects data and runs agreed methodology.  

•  Consultant reviews the existing voluntary watch list and list facilitating (substances with enough 
monitoring information that can be proposed for the GWD Annexes review) with a view adding 
substances to the lists.  

•  The review of the voluntary WL list and list facilitating is  carried out in consultation with the 

group of volunteers (within WG Groundwater).  

•  The  Commission  agrees  (Water  Directors  acknowledge)  on  a  new  voluntary  watch  list.  The 
Commission considers list facilitating for the formal process of the GWD Annexes review.  
•  Member  States  perform  monitoring  on  voluntary  basis  for  the  watch  list  and  list  facilitating 
substances and report data to consultant. For quality standards and threshold values MS report on 
89 

 
 
 
 
pollutants  causing  failure  and  risk,  exceedances  and  trends  (among  other)  though  established 
WFD reporting system.  

•  Consultant assesses data provided on voluntary basis. EEA analyses the reported monitoring data 

under WFD scheme. 

Changes envisaged as part of reattribution: Yes 

- 

In the past only voluntary watch list under groundwater directive. Obligatory watch list would 
be new. 

-  New legal task: EU-wide EQS for substances listed in a (new) Annex II of the EQSD including 

the so-called ‘River Basin Specific Pollutants’; 

-  New legal task: EU wide threshold values for pollutants listed in Annex II GWD (where too 

wide divergences exist between national standards); 

-  Explicit identification, within 2 years of entry into force, of suitable monitoring methods for 
monitoring  and  analysis  of  PFAS,  and  for  microplastics  and  Antimicrobiotical  resistance 
genes (AMR)[2 years], for both SW and GW (in addition to the regular verification of the 
suitability and availability of monitoring and analytical methods not entailing significant costs 
for substances proposed to be listed in the Watch Lists under both directives)  

-  Groundwater  Directive:  verification  of  the  suitability  and  availability  of  monitoring  and 
analytical methods not entailing significant costs, and compilation of information on these for 
MS. This task existed, but was never performed. 

Proximity to ECHA mandate: The works seems close to the ECHA core mandate, especially for 
the EQSD / priority setting. ECHA already has the required expertise/competence for deriving EQSD 
(PNECs).  

Projected synergies and added value of reattribution: 

Type 

Synergies 

Reuse of 
capabilities 

High 

Process and expertise: ECHA already supports similar work on 
substance restrictions, including safe limit value setting under 
REACH and other legislation. Several key capacities can be 
reused/reinforced: 

-  Hazard, risk, exposure and socio-economic assessment 
-  Committee opinion development 
- 

IT capabilities for stakeholder consultation and 
dissemination (including regulatory intentions) 

Re-use of data  High 

Reuse of data collected under other chemical legislation. 

Workload 
balancing 

Medium  With work culminating in 3 and 6-year cycles, the workload of 

Agency experts and Committee experts can be balanced (although 
work will be permanently ongoing and resource estimates are 
already annualised). 

High 

IT tools: 
automation 
and economies 
of scale 

Not an IT-intensive process, but reuse of IT capabilities for case 
management, public consultation, interaction with Member States, 
regulatory intentions management and data dissemination. ECHA is 
also requested to build an EU repository of health limit values, 
including EU and national EQS, building further on existing tools. 

90 

 
 
 
 
High 

Support 
services: 
economies of 
scale 

Reuse of scientific support services (e.g. committee secretariat, 
prioritisation and grouping of substances, substance identification, 
data management and dissemination). Reuse of administrative 
services. 

Type 

Added value 

Scientific 
consistency 

High 

Opportunity to align priority setting, timeline, process and 
methodology with other related legislation to improve coherence in 
the scientific advice provided to the Commission. Reuse of data 
collected under other chemical legislation. 

Robustness of 
assessment and 
acceptance 

High 

Independence  High 

Insourcing of scientific work from consultants and dispersed 
Commission services to one central EU Agency and its experts. 
Involvement of RAC and SEAC committees adds more scientific 
robustness to the process. 

(See also European Court of Auditors: External consultants at the 
European Commission - Scope for reform). 

Moving scientific work from consultants and dispersed 
Commission committees to Agency experts and well-established 
committees in the European Chemicals Agency with a stricter 
separation between science and policy. ECHA and its committees 
work under stricter conflict of interest avoidance rules, improving 
guarantees of independent scientific advice to the Commission. 

Transparency  High 

ECHA’s involvement will bring additional transparency to the 
process: 

-  Overall process transparency 
-  Publication of regulatory intentions of EU authorities 
improves predictability for industry stakeholders 

-  Public consultation/call for evidence 
-  Stakeholder involvement/observer status 
-  Dissemination of scientific data and outcomes 

Main risks and opportunities:  The scope of EQSD / priority setting includes all chemicals, also 
pesticides,  pharmaceuticals,  etc.  ECHA  will  need  to  see  how  it  collects  data  on  pesticides  and 
pharmaceuticals in practice. 

Projected impact on ECHA:  

•  ECHA  Committees/bodies:  high  impact.  The  task  generates  major  impact  on  the  setup  / 
organisation / staffing of Committees/bodies due to the additional workload. The committees 
expertise is adequate. No new expertise of the committee is needed. 

RAC 

# of 
opinions 
per year 

rapportuer  Type of 
opinion 

SEAC 

# of 
opinions 
per year 

rapporteur  Type of 
opinion 

91 

 
 
 
 
 
 
 
 
 
 
GWD Annex I   1  

GWD Annex 
II 

EQSD Annex 
I 

EQSD Annex 
II 

1 

4 

1 

ECHA 

ECHA 

ECHA 

ECHA 

1  

1 

4 

1 

ECHA 

ECHA 

ECHA 

ECHA 

•  ECHA data model and IT infrastructure: low impact. The task can be implemented with 

adjustments / configuration of existing data structures and IT systems 

•  ECHA key experts: high impact. The task relies on existing expert competencies, which are 

limited within ECHA and also critical to REACH/CLP/BPR regulatory tasks 

Projected workload and resource implications  

Financial resource needs 

Human resource needs 

Approximately: 11 FTEs 

Candidate for funding from fees? 

No 

Current workload volume and resources spent in Commission 

In summary the current resources spent are: 

Current budget line 

JRC  +  JRC  consultants for  EQS  surface  water 
and Watch List surface water 
DG ENV consultants for impact assessment for 
EQS surface water 
DG  ENV  consultants  for  voluntary  watch  list 
groundwater  
SCHEER  Committee  members  +  external 
experts 

DG SANTE SCHEER Committee secretariat 

Budget line of DG ENV (+JRC) + budget line of 
DG SANTE 
Ca. 4.5 FTE (1 FTE regular JRC staff + 3.5 FTE 
contracted by EUR 232 030 per year) 
Ca.  0.25  FTE  (contracted  by  EUR  16  700  per 
year) 
Ca.  0.16  FTE  (contracted  by  EUR  10  560  per 
year)  
Ca.  30%  of  work  time  (average  over  all  the 
years) of SCHEER membership  

•  EUR 79 200 for reimbursement (30% of 
EUR 240 000) or up to EUR 93 134 for 
the year at the peak 

Ca.  1.00  FTE  (ca.  30%  of  work  time  (average 
over all the years) of 2 + 1 FTE) 
Ca. 6.00 FTE 

Total 
(to convert the cost of consultants into FTEs, the cost of 1 FTE consultant is estimated at ca. EUR 
66 000 EUR annually) 

Such  Commission  resources  do  not  include  contributions  to  the  administrative  overhead  of  the 
Commission (HR, Finance, IT tools, etc.). 

Past workload for EQSD (surface water) (Budget line of ENV and SANTE)  

92 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Watchlist surface water: 

-  Review of ca. 10 substances / every 2 years 

Prioritisation and EQS derivation  

The  Priority  List  went  from  33  to  45  substances  in  2013  and  will  grow  with  an  additional  22 
substances in 2022. From that list the SCHEER provided opinions on a total of 45 EQS during the 
last 10-12 years (average of 4 EQS per year) as follows: 

•  2022: EQS for 14 priority substances + 4 pending + groundwater standards pending for 

several substances 

•  2021: EQS for 3 priority substances 
•  2012: EQS for 1 substance 
•  2011: EQS for 23 substances 

Also,  if  one  looks  at  the  last  6-year  review  cycle  in  2022  when  22  substances  were  added  to  the 
Priority List, one comes to an average of 4 substances per year if the workload needs to be annualised. 

Past workload for groundwater: 

In the past only voluntary watch list under groundwater directive. Obligatory watch list would be 
new, align two directives. Currently only 2 pharmaceuticals for EU standard and 1 for MS monitoring. 
A few substances will be added in 2022. 

Resources used currently for EQSD (surface water): 

Watchlist and derivation of EQS for new Priority (hazardous) substances is currently led by JRC (in 
house and contractors) and the list of P(H)S and related EQS are submitted to a SCHEER opinion. 
SCHEER has delivered 45 opinions in the period between 2011 – 2022 (average of 4/year). IA of 
EQS proposals  for new substances on the PS list outsourced to  contractor; regular discussion and 
presentation in Working Group Chemicals. 

JRC staff permanent+ JRC consultant work Watch List and Annex I EQS list PS and EQS = EUR 1 
392 181 (AAs with JRC) over 6 years, i.e. EUR 232 030 per year; if we calculate yearly consultant 
cost at EUR 66 000, this would make ca 3.5 FTE plus 1 FTE (one permanent staff)/year.  

In addition, part of the impact assessment was carried out under IA contract DG ENV = relevant part 
of IA contract was about EUR 100 000; i.e. Ca. 1.5 FTE over six years = 0.25 FTE per year 

The SCHEER Committee serves water legislation for approximately 1/3rd of its capacity (17 opinions 
out of 51 during 2016-2022). SCHEER has 17 (external) scientists per mandate that are remunerated 
for their work. DG SANTE provides the secretariat to the SCCS and SCHEER that consists of 4 FTE 
+  2  FTE  for  technical  and  administrative  support  (literature  search,  editing  and  proofreading  of 
opinions, website mastering, assistance for the Health-EU newsletter, dissemination activities). Costs 
for renumeration of members of the committee are ca. EUR 93 134 per year (30% of 310 447,08 
(the  total  cost  of  SCHEER  activities  in  2019  consisting  of  indemnities,  travel  cost  and  daily 
allowances for the members).  

The total resources used: 6.1 FTEs (4.5 FTE/year (Scientific work) + 1.35 FTE/year (committee 
secretariat) + 0.25 FTE/year (impact assessment via contract)) + costs of renumeration of members 
of the committee of ca. EUR 93 134 per year 

93 

 
 
 
 
Resources used currently for GWD (ground water) 

No JRC involvement currently, most work on voluntary watch list mechanism is done by MS expert 
group  and  contractor;  outcome  of  that  work  is  sent  to  SCHEER  for  updating  of  Annex  I;  for  the 
current  proposal  of  additional  4  groups  of  substances  one  single  opinion  was  provided  (one  file 
covering all pollutants). 

DG ENV consultants for voluntary watch list groundwater = 4 low volume contracts at cost of EUR 
57 000  = approximately 1 FTE over six years = 0.16 FTE per year 

In addition: contributions from MS; EC and JRC permanent staff (already estimated under ‘Surface 
water’ and SCHEER opinion (one opinion on total amount of substances proposed for Annex I).  

Future policy trends, workload drivers and ECHA resource needs 

Commission’s calculation method: 

If we estimate the additional cost of the new tasks introduced under the proposal, i.e. additional 2 
EQS per year for Annex II EQSD and GWD and additional 1,5 substances/pollutants to be identified 
per  year  for  Watch  List  GW  (proposed  5  substances  every  3  years,  i.e.  10  over  six  years  i.e. 
approximately 1.5 per year): so this would add up to approximately 35% of the current 6.26 FTE (4 
opinions per year, plus Watch List with double amount of substances), i.e. in total 6.26 FTE plus 2.25 
FTE which would make approximately 8.5 FTE. 

To compare this estimate of current expenditure with the proposal from ECHA we would need to add 
the estimated amount for the development and/or identification of monitoring and analysis methods 
for total  PFAS  (note that for microplastics and for AMR,  since these will be part of the ‘normal’ 
Watch  list  mechanism,  the  identification  of  methodologies  would  supposedly  be  covered  by  the 
normal ‘Watch list support’); 

For  JRC  is  currently  working  on  a  methodology  for  measuring  microplastics  in  drinking  water 
(budget of EUR 300 000), to be adopted by delegated act in Jan 2024. A contract is being launched 
for the development of technical guidelines on analytical methods for PFAS (mainly ‘PFAS Total’) 
in drinking water (budget EUR 200 000); also to be established by Jan 2024. It is likely that the work 
required for developing or identifying methodologies for microplastics and total PFAS in surface and 
in  groundwater  bodies  will  benefit  from  the  work  carried  out  under  the  drinking  water  directive, 
possibly resulting in slightly lower estimates. 

ECHA’s calculation method: 

The priority setting process is similar work to REACH Annex XIV prioritisation, while the setting of 
EQS as well as reviewing the substances and quality standards in Annexes I and II to the GWD) is 
assumed similar to deriving Occupational Exposure Limits (OELs), with an average cost in ECHA 
of 0.7 FTE / substance. This however does not yet include the provision of a socio-economic analysis 
/ impact assessment via the SEAC committee, which would add an additional 0.3-0.5 FTE (estimate 
made in the past for possible socio-economic assessment work for OELs). 

Also, the surface water and groundwater watchlist process, and especially the setting of PNECs, is 
assumed similar to deriving OELs, with an average cost in ECHA of 0.7 FTE / substance. However, 
this process would potentially not include committee opinion forming, so the cost is estimated to be 
half lighter at 0.35 FTE / substance. 

94 

 
 
Annual ECHA resource needs: 

•  The following resource estimates correspond to the “ECHA way”, i.e. implementing similar 
processes and similar level of digitalisation to what is in place for ECHA’s current tasks. Such 
examples would be the creation of registries of intentions and the dissemination of lists (watch 
lists, priority lists) as structured data. The benefit of this approach is to ensure a consistent 
standard of scientific quality, transparency, data searchability and interoperability. 

• 

•  Both for Groundwater and surface water: verification of the suitability and availability of 
monitoring  and  analytical  methods  not  entailing  significant  costs,  and  compilation  of 
information on these for MS: 0.5 FTE for running a public consultation on available methods, 
scientific support and contract management of the second part of the task to assess suitability 
of analytical methods which would be outsourced to a scientific institute at ca. EUR 70 000 
annually; 
Identification  of  suitable  monitoring  and  analytical  methods  for  microplastics,  PFAS  and 
AMR within two years after entry into force: resource needs covered under the bullet point 
above; 
Identifying and setting PNECs for 5 groundwater watch list substances every 3 years: 0.5 
FTE annually (~unit cost of 1 ‘light’ OEL without committee involvement = 0.35 FTE); 
•  Groundwater:  Specific  technical  work  on  six-yearly  review  of  the  pollutants  and  quality 
standards in Annex I and possible updating of Annex II (listing pollutants for which MS must 
set national thresholds) to the GWD: six year cycle review of the pollutants listed in the two 
annexes and of the quality standards in Annex I. Development of proposals for the amendment 
of Annexes I and II, based on scientific and technical evidence: review 1 substance annually: 
1 FTE annually (~unit cost of 1 OEL, incl. RAC + SEAC = 1 FTE); 

• 

• 

•  Priority setting process groundwater, identifying substances where national thresholds apply 
but wide divergences exist, identification of EU wide thresholds for pollutants in Annex II; 
one per year, to be included in a delegated act every six years: 1 FTE annually (~unit cost of 
1 OEL, incl. RAC + SEAC = 1 FTE); 
Identifying and setting PNECs for 10 surface water watch list substances every 3 years: 1.05 
FTE annually (~unit cost of 1 ‘light’ OEL without committee involvement = 0.35 FTE); 
•  Setting  of EQS for Priority List substances for ca. 4  surface water substances  annually + 
RAC  committee  opinion  forming  +  SEAC  committee  opinion  forming:  4  FTE  annually 
(~unit cost of 1 OEL, incl. RAC + SEAC = 1 FTE); 

•  Technical work under surface water on establishing EU-wide EQS for substances listed in a 
(new)  Annex  II  of  the  EQSD  including  the  so-called  ‘River  Basin  Specific  Pollutants’ 
formerly  part  of  the  ‘ecological  status’  component  of  surface  water  status:  assumption  of 
setting EQS for 1 substance per year: 1 FTE annually (~unit cost of 1 OEL, including RAC 
+ SEAC = 1 FTE); 
IT tools and infrastructure development and run cost (data submission, processing, output): 
contribution of 10% for common components and customisations; 

• 

•  Horizontal support (governance & enablers / administrative overhead): contribution of 15%. 

----------- 

Ca. 2.5 FTE for groundwater 

Ca. 6.05 FTE for surface water 

+ 0.5 FTE + 70k EUR for analytical methods for both groundwater and surface water 

+ 10% IT tools and infrastructure (would be approximately 1 FTE) 

+ 15% administrative overhead (would be approximately 1.5 FTE) 

95 

 
 
-------- 
Total: ca. 11 FTEs plus EUR 70 000 for outsourcing of identification of monitoring methodologies 

Summary of additional resource needs for Environmental Quality Standard Directive 
(2008/105/EC) + Water Framework Directive (2000/60/EC) + Groundwater Directive 
(2006/118/EC): 

Agency 

Summary of tasks 

Resource needs 

EEA 

Operational resource needs: 

Human resource needs: 

ECHA 

Operational resource needs: 

Human resource needs: 

2024: EUR 130 000  
2025: EUR 80 000 
2026: EUR 80 000 
2027: EUR 80 000 
2024: 3 TAs, 0 CA 
2025: 3 TAs, 0 CA 
2026: 3 TAs, 0 CA 
2027: 3 TAs, 0 CA 
2024: EUR 673 000  
2025: EUR 686 000 
2026: EUR 702 000 
2027: EUR 718 000 
2024: 7 TAs, 4 CA 
2025: 7 TAs, 4 CA 
2026: 7 TAs, 4 CA 
2027: 7 TAs, 4 CA 

Future budget line: DG Environment  

Candidate for fees: No 

9.  CLP REGULATION (1272/2008) 

Responsible body: 

Currently: N/A 

(Re-)attribution planned to: ECHA, EFSA 

Legal basis for reattribution: Revision of the CLP Regulation  

Type of task: New 

Brief task overview:  

1.  Developing a proposal for harmonised classification 

2.  Opinion on a proposal for harmonised classification  

Detailed process description: 

Current process: 

For  hazards  of  highest  concern  (carcinogenicity,  mutagenicity,  reproductive  toxicity  (CMR)  and 
respiratory sensitisers) and for other substances on a case-by-case basis, classification and labelling 
should  be  harmonised  throughout  the  EU  to  ensure  an  adequate  risk  management.  This  is  done 
through  harmonised  classification  and  labelling  (CLH).  Harmonised  classifications  are  listed  in 
Annex VI to the CLP Regulation. 

The process for harmonised classification is as follows: 

i.  Member State (or industry under certain conditions) submits proposal for harmonised 
classification to ECHA. There is no legal obligation to do this; it is at the MS’ (or 
industry’s) discretion.  

96 

 
 
 
 
 
 
ii.  RAC provides an opinion on harmonised classification.  
iii. 
iv. 

ECHA sends opinion to COM 
‘Where appropriate’, COM formalises classification through addition of substance to Annex 
VI to CLP 

Future process: 

ECHA  or  EFSA,  on  the  request  of  the  Commission,  will  be  obliged  to  develop  a  proposal  for 
harmonised classification.  

Proximity to Agency mandate:  The task fits  well with  the mandates of  ECHA and EFSA. Both 
agencies are already involved in hazard and risk assessment of chemicals. ECHA already manages 
the process of RAC opinion making on proposals for harmonised classification and other provisions 
of CLP regulation.  

Projected synergies and added value of reattribution:  Higher capacity to  agree on harmonised 
classification for substances and the possibility to solve divergent opinions among agencies as regards 
hazard assessment is the key added value.  

Type 

Synergies 

Reuse of 
capabilities 

High 

Process and expertise: ECHA already supports work under the CLP 
regulation including opinion making on harmonised classification and 
performs risk and hazard assessment under other pieces of legislation. 
Several key capacities can be reused/reinforced: 

-  Hazard assessment 
-  Committee opinion development 
-  Existing  IT  capabilities  for  dossier  submission,  stakeholder 

consultation and dissemination 

Re-use of 
data 

Workload 
balancing 

IT tools: 
automation 
and 
economies of 
scale 

Support 
services: 
economies of 
scale 

Medium  Reuse  of  substance  identification  and  hazard  data  collected  under 

other chemical legislation.  

Low 

High 

High 

With an estimated workload of developing 5 proposals annually, there 
is little room for workload balancing. 

Reuse  of  IT  capabilities  for  case  management,  public  consultation, 
interaction  with  Member  States,  regulatory  intentions  management 
and data dissemination. 

Reuse  of  scientific  support  services  (e.g.  committee  secretariat, 
prioritisation  and  grouping  of  substances,  substance  identification, 
data  management  and  dissemination).  Reuse  of  administrative 
services. 

Type 

Added value 

Scientific 

High 

Opportunity to solve divergent opinions among agencies as regards 

97 

 
 
 
 
 
consistency 

hazard assessment.  

Projected impact on ECHA and EFSA: 

•  ECHA Committees/bodies: high impact. The task requires involvement of ECHA committee 

RAC. EFSA Committees/bodies: no impact. No involvement of EFSA’s committees  

RAC 

# of 
opinions 
per year 

rapporteur  Type of 
opinion 

SEAC 

# of 
opinions 
per year 

rapporteur  Type of 
opinion 

Harmonised 
classification  

6 

ECHA staff 

0 

•  ECHA  data  model  and  IT  infrastructure:  low  impact.  The  task  can  be  implemented  with 
adjustments / configuration of existing data structures and IT systems; EFSA data model and 
IT infrastructure: no impact. The task does not require use of IT infrastructure.  

•  ECHA key experts: high impact. The task relies on expert competencies, which are limited 
in ECHA and also critical to other regulatory tasks. EFSA key experts: high impact. The task 
relies on expert competencies, which are limited in EFSA and also critical to other regulatory 
tasks.  

Workload and resource implications: 

Current workload and resource use: 

Number of RAC opinions on harmonised classifications managed by ECHA varies per year, with an 
average of 47 opinions per year:  

Number of opinions per year 

Opinions on 

2016  2017  2018  2019 

2020 

2021 

Classification (CLH) 

35 

33 

61 

51 

49 

53 

Based  on  the  analysis  provided  by  ECHA  (which  was  based  on  the  analysis  of  ECHA  and  MSs 
spending on preparation of classification dossiers), the dossier for harmonised classification which is 
of average complexity requires 0,5 FTE and 95k EUR: 

ECHA’s estimate of resources for supporting the preparation of a CLH dossier of medium complexity 

Dossier development 
RAC opinion making 
Support services 
Total FTE 

95K EUR: 

estimate for CLH 
0.35 FTE 
0.1 FTE 
0.05 FTE 
0.5 

•  Title 1 Staff expenditure: EUR 85 000, including 19% overhead cost 
•  Title 2 Infrastructure: included under Title 1 above 
•  Title 3 Operational costs: EUR 10 000  

The dossier of high complexity, requires 0.65 FTE and EUR 120 000:  

ECHA’s estimate of resources for supporting the preparation of a complex CLH dossier 

Dossier development 

ECHA estimate for CLH 
0.5 FTE 

98 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
RAC opinion making 
Support services 
Total FTE 

EUR 120 500: 

0.1 FTE 
0.05 FTE 
0.65 

•  Title 1 Staff expenditure: EUR 110 500, including 19% overhead cost 
•  Title 2 Infrastructure: included under Title 1 above 
•  Title 3 Operational costs: EUR 10 000 

The CLH dossier of low complexity requires 0.35 FTE and EUR 69 500 

ECHA’s estimate of resources for supporting the preparation of a CLH dossier of low complexity 

Dossier development 
RAC opinion making 
Support services 
Total FTE 

EUR 69 500: 

estimate for CLH 
0.2 FTE 
0.1 FTE 
0.05 FTE 
0.35 

•  Title 1 Staff expenditure: EUR 59 500, including 19% overhead cost 
•  Title 2 Infrastructure: included under Title 1 above 
•  Title 3 Operational costs: EUR 10 000 

ECHA and EFSA do not prepare any proposals for harmonised classifications. 

Future workload and resource needs: 

Based on the impact assessment, it is expected that additional 250 dossiers will have to be prepared 
over the next 20 years, i.e. 12.5 dossiers per year. It is expected that the dossiers to be prepared are to 
be of lower complexity than medium, but higher than low complexity dossiers, i.e. having an average 
resource requirement of 0.4 FTE per dossier. This would result in the need of 5 FTEs per year to 
process 12.5 dossiers/year. Normally, there is a need for the contribution of 15% for the development 
and  maintenance  of  common  IT  components  (0.75  FTE)  and  for  the  contribution  of  15%  for  the 
horizontal support (governance & enablers / administrative overhead) (0.75 FTE per year). However, 
as this is an extension of existing CLH process in the agency and the process and structures are fully 
in place, there is no need for these additional overhead contributions. Therefore, in total, there is a 
need of 5 FTEs per year.  

EFSA will need to prepare up to 1 dossier per year, which is possible to be absorbed by its resources 
for the plant protection products.  

Summary of additional resource needs for the CLP regulation: 

Agency 

ECHA 

Summary of tasks 

- Preparing classification dossiers (12.5 per 
year) 
- Assessing classification dossiers (13.5 per 
year) 

EFSA 

- Preparing classification dossier (1 per year) 

Resource needs 

Financial resource 
needs: 

Human resource 
needs: 

Financial resource 
needs: 

Human resource 
needs: 

2024: EUR 0  
2025: EUR 0 
2026: EUR 0 
2027: EUR 0 
2024: 3 TA, 2 CA 
2025: 3 TA, 2 CA 
2026: 3 TA, 2 CA 
2027: 3 TA, 2 CA 
2024: EUR 0  
2025: EUR 0 
2026: EUR 0 
2027: EUR 0 
2024: 0 FTE 
2025: 0 FTE 
2026: 0 FTE 

99 

 
 
 
 
2027: 0 FTE 

Future budget line: DG GROW  

Candidate for fees: No 

10.  PACKAGING AND PACKAGING WASTE DIRECTIVE  

Responsible body: 

Currently: N/A, no current process for hazardous substances 

(Re-)attribution planned to: ECHA 

Legal basis for reattribution: revision of the Packaging and Packaging Waste Directive 
(94/62/EC) 

Type of task: New – expanding the existing REACH restriction process and  

Brief task overview: Assessments underpinning restrictions of substances in packaging and 
performing a scoping study for substances in packaging that would be candidates for restriction. 

Detailed process description: 

New process:  

If there is a need to restrict a substance in packaging, restriction process under REACH shall be used 
for that purpose.  

The  study  will  aim  at  collecting,  identifying  and  prioritising  relevant  substances  of  concern  in 
packaging for which potential limitations or restrictions could be envisaged. This study will draw on 
available information and registers covering substances of concern to enable an initial prioritisation 
for swift further restriction action, as appropriate. This study, will determine the conditions under 
which the concentration level of certain substances of concern, do not apply to recycled materials and 
to product loops which are in a closed and controlled chain. It will also detail the reasoning of setting 
exemptions from the requirements of the proposed regulation for certain types of packaging. 

Proximity to ECHA mandate: This task fits very well with the ECHA’s core mandate, as it is a 
REACH restriction. ECHA holds the right competences to manage the packaging restriction process, 
however, does not have sufficient information on the exact use of substances in packaging. 

Projected synergies and added value of reattribution: 

This reattribution ensures maximal synergies and coherence of scientific opinions. The same process 
and the same scientific methodologies as in REACH will be used. The substances under scrutiny are 
the same or similar to those under REACH (and other legislation supported by ECHA) and REACH 
(and other ECHA) data and processes can be reused for packaging restriction dossier development 
and opinion forming. All needed competencies for the task exist in ECHA. 

Projected impact on ECHA  

-  ECHA Committees/bodies: medium impact. The task generates medium impact on the 
setup / organisation / staffing of Committees/bodies due to the additional use to be 
considered in the restriction  

RAC 

# of 
opinions 
per year 

rapporteur  Type of 
opinion 

SEAC 

# of 
opinions 
per year 

rapporteur  Type of 
opinion 

100 

 
 
  
 
 
 
 
 
 
0 

Restriction in 
packaging and 
packaging 
waste 

RAC 
member 

0 

SEAC 
member 

-  ECHA data model and IT infrastructure: low impact. The task can be implemented with 

adjustments / configuration of existing data structures and IT systems 

-  ECHA key experts: medium impact. The task heavily relies on expert competencies, which 

are limited within ECHA and also critical to REACH/CLP/BPR regulatory tasks 

Projected workload and resource implications  

Current workload and resource use:  

N/A, no current process for hazardous substances. 

Future workload and resource needs: 

It can be expected that at most 1 restriction of a substance will be needed once per two years, i.e. 0.5 
restriction  per  year.  This  would  require  0.5  FTE  per  year.  In  addition,  there  is  a  need  for  the 
contribution of 15% for the development and maintenance of common IT components (0.1 FTE per 
year)  and  for  the  contribution  of  15%  for  the  horizontal  support  (governance  &  enablers  / 
administrative overhead): (0.1 FTE per year). In total, there is a need of 0.7 FTE per year. Considering 
the fact that these restrictions will be performed as REACH restrictions, possibly merging restriction 
in packaging with restriction of the same substance in another uses, the work resources can be covered 
by the available resources for REACH restriction.  

The performing of the scoping study will require a dedicated person for 3 years to compile and analyse 
the necessary information leading to the identification and prioritisation of substances that need to be 
considered for the restriction in packaging. The work is the best to be performed by the large part by 
the internal ECHA staff as the access to all information on chemicals and materials is needed. It is 
estimated that 1 FTE for 3 years would be necessary to perform such study. Some subcontracting 
may be possible to get more information on the insight of the use of chemicals in packaging.  

Summary of additional resource needs for packaging and packaging waste directive: 

Agency 

ECHA 

Summary of tasks 

- Processing at most 0.5 restriction dossiers 
per year (including RAC and SEAC opinion) 
as part of REACH restriction  

- Performing a scoping exercise related to 
presence of chemicals in packaging 

Resource needs 

Financial resource 
needs: 

Human resource 
needs: 

2024: EUR 0  
2025: EUR 0 
2026: EUR 0 
2027: EUR 0 
2028: EUR 0 
2024:  0 TA, 0 CA 
2025:  1 TA, 0 CA 
2026:  1 TA, 0 CA 
2027:  1 TA, 0 CA 
2028:  0 TA, 0 CA 

Future budget line: DG Environment 

Candidate for fees: No 

11.  LEGISLATION ON MEDICINAL PRODUCTS FOR HUMAN USE (726/2004) 

Responsible body: 

101 

 
 
 
 
 
 
 
Currently: EMA 

(Re-)attribution planned to: EMA, expanding and modifying the existing tasks and adding new tasks 

Legal basis for reattribution:  

Proposal for a Directive of the European Parliament and of the Council on the Union code relating to 
medicinal products for human use, and repealing Directive 2001/83/EC and Directive 2009/35/EC 
(COM (2023) 192 final) 

Proposal  for  a  Regulation  of  the  European  Parliament  and  of  the  Council  laying  down  Union 
procedures for the authorisation and supervision of medicinal products for human use and establishing 
rules  governing  the  European  Medicines  Agency,  amending  Regulation  (EC)  No  1394/2007  and 
Regulation  (EU)  No  536/2014  and  repealing  Regulation  (EC)  No  726/2004,  Regulation  (EC)  No 
141/2000 and Regulation (EC) No 1901/2006 (COM (2023) 193 final) 

Type of task: New and modified existing ones 

Process description: 

New/modified processes: 
The  details  of  the  new  and  modified  tasks  are  provided  in  the  proposal  for  the  directive53,  the 
regulation with accompanying legislative financial statement54 and the accompanying staff working 
documents55,56,57.  

In short:  

Specific objectives of the legislative proposals are: 

1.  Promote innovation, in particular for unmet medical needs, including for rare disease 

patients and children.  

2.  Create a balanced system for pharmaceuticals in the EU that promotes affordability for 

health systems while rewarding innovation.  

3.  Ensure access to innovative and established medicines for patients, with special attention to 

enhancing security of the supply across the EU.  

4.  Reduce the environmental impact of the pharmaceutical product life cycle.  

5.  Reduce the regulatory burden and provide a flexible regulatory framework. 

The main requirements of the proposals to be met in the short and long term are:  

•  Upon the entry into force of the Regulation, the Agency should put in place the framework which 
will  be  used  to  enhance  regulatory  support  and  accelerated  assessment,  to  address  medicine 
shortages and supply chain challenges and to strengthen the environmental risk assessment under 
the marketing authorisation.  

•  Regarding the enhanced regulatory support, the Agency shall set up within 6 months of adoption 
a coordination mechanism to enable parallel scientific advice with health technology assessment 
and regulatory bodies for medical devices. Within the same period, the Agency shall create an 

53 Proposal for a Directive of the European Parliament and of the Council on the Union code relating to medicinal 
products for human use, and repealing Directive 2001/83/EC and Directive 2009/35/EC (COM (2023) 192 final). 
54 Proposal for a Regulation of the European Parliament and of the Council laying down Union procedures for the 
authorisation and supervision of medicinal products for human use and establishing rules governing the European 
Medicines Agency, amending Regulation (EC) No 1394/2007 and Regulation (EU) No 536/2014 and repealing 
Regulation (EC) No 726/2004, Regulation (EC) No 141/2000 and Regulation (EC) No 1901/2006 (COM (2023) 193 
final). 
55 EUR-Lex - 52023SC0191 - EN - EUR-Lex (europa.eu) 
56 EUR-Lex - 52023SC0192 - EN - EUR-Lex (europa.eu) 
57 EUR-Lex - 52023SC0193 - EN - EUR-Lex (europa.eu) 

102 

 
 
 
Academia Office, a secretariat to support not-for-profit entities by providing them free of charge 
early  scientific  advice.  Furthermore,  the  Agency  shall  establish  an  EU  inspectorate  within  the 
Agency, to strengthen the network’s inspection capacity and deal with emergencies, similar what 
was needed during the pandemic. 

•  For  addressing  medicine  shortages  the  Agency  shall  extend  the  monitoring  and  management 
capacity for  all shortages, with  a focus on critical  shortages,  and extend the EMA  capacity to 
support would facilitate availability of critical medicinal products. This appropriate availability 
and access to medicinal products which may have a serious impact on public health.  

•  The  Agency  shall  also  extend  its  capacity  to  support  the  enhanced  environmental  risk 

assessments. 

The modified or new tasks that are related to the one substance, one assessment approach are:  

•  developing  coherent  scientific  assessment  methodologies  in  the  fields  falling  within  EMA 

mission; 

•  cooperating with EU decentralised agencies and other scientific authorities and bodies established 
under Union law, notably the European Chemicals Agency, the European Food Safety Authority, 
the European Centre for Disease Prevention and Control and the European Environment Agency 
as regards the scientific assessment of relevant substances, exchange of data and information and 
development  of  coherent  scientific  methodologies,  including  replacing,  reducing  or  refining 
animal testing, taking into account the specificities of the assessment of medicinal products; 

• 

• 

take the necessary and appropriate measures to monitor and identify at an early stage any potential 
source of divergence between its scientific opinions and the scientific opinions issued by other 
Union bodies and agencies carrying out similar tasks in relation to issues of common concern. 
Where the Agency identifies a potential source of divergence, it shall contact the body or agency 
in question to ensure that all relevant scientific or technical information is shared and in order to 
identify potentially contentious scientific or technical issues. Where a substantive divergence over 
scientific or technical issues is identified and the body concerned is a Union Agency or a scientific 
committee, the Agency and the body concerned shall cooperate to resolve the divergence, and 
inform the Commission without undue delay.  

to enable coherence between scientific opinions and to avoid duplication of tests, EMA shall make 
arrangements  with  other  bodies  or  agencies  established  under  Union  law  for  cooperation  on 
scientific assessments and methodologies. EMA shall also make arrangements for the exchange 
of data and information on relevant substances with the Commission, Member States’ authorities 
and other Union Agencies, in particular for environmental risk assessments, non-clinical studies 
and maximum residue limits. These arrangements shall seek to ensure that exchanges of data and 
information  are  made  available  in  electronic  formats  and  shall  protect  the  commercially 
confidential nature of the information exchanged and be without prejudice to the provisions on 
regulatory protection. 

•  electronic  applications  for  marketing  authorisations  and  for  variations  to  the  terms  of  the 
marketing authorisations shall be introduced to avoid unnecessary administrative and financial 
burden both for the pharmaceutical industry and the competent authorities and EMA shall make 
available such electronic formats. 

•  EMA shall set-up an active substance based  review system  of environmental risk assessments 
(‘ERA  monographs’)  for  authorised  medicinal  products.  An  ERA  monograph  shall  include  a 
comprehensive set of physicochemical data, fate data and effect data based on an assessment of 
active substances.  

103 

 
 
Proximity to Agency mandate: The tasks fit well with the mandate of EMA as all three tasks target 
the areas of the EMA mandate, and they are either an expansion of existing tasks or addition of new 
tasks related to medicines. 

Projected  synergies  and  added  value  of  reattribution:  Improving  coherence,  consistency  and 
interoperability among the Agencies work is the key added value.  

Workload and resource implications: 

Future workload and resource needs: 

The new tasks require additional resources for EMA. The additional resource needs are mainly related 
to additional tasks to be carried out by EMA in terms of providing scientific, administrative and IT 
support in the following main areas:  

•  enhanced pre-authorisation scientific and regulatory support;  
•  decision-making on orphan designations and management of the Union Register of designated 

orphan medicinal products;  

inspection capacities for inspections in third countries and support to Member States;  

•  active substance master file assessment and certification;  
• 
•  environmental risk assessment strengthening;  
•  shortage management and security of supply. 

As  described  in  the  legislative  financial  statement  accompanying  the  proposals,  the  following 
resources are needed:   

•  6 FTEs (4 AD and 2 AST TAs) are necessary to set up the Academia Office at EMA that will 
be managing the procedures. The tasks of the office will be similar to the tasks of the SME 
office and will include procedural and administrative assistance to “not-for-profit” entities, 
including direct assistance and briefing meetings on regulatory strategy, providing fee waivers 
and  reductions  to  eligible  entities,  provide  free-of-charge  translations  of  the  product 
information in all EU languages for initial EU marketing authorisations, provide training and 
education to “not-for-profit” entities, etc 

•  54 FTEs: 

o  managing (AD profiles) and providing support (AST profiles) to operational expert 

groups in the area of the Environmental Risk Assessment (ERA);  

o  with  a  scientific  and  regulatory  profile  to  work  in  the  shortages  management  and 

security of supply;  

o  Good Manufacturing Practice and Good Clinical Practice inspectors (AD) necessary 
to establish an EU inspectorate resourced by EMA staff that would provide help to the 
inspections  done  by  Member  States  (lacking  resources),  and  deal  with  emergency 
situations  which  require  dedicated  and  dependable  intervention  (e.g.,  similar  to 
inspections required during the pandemic);  

o  Legal officers (AD profiles), needed in the field of orphan designations that are already 
today  a  litigious  topic  and  so  it  is  assumed  the  proposed  changes  in  the  decision 
making on orphan designation would generate an increased in workload for even more 
legal queries and litigations;  

o  defining  business  requirements  for  the  data  register,  following  up  on  the 
implementation and perform the related scientific activities when the register is live;, 
develop trainings on ERA, etc.;  

104 

 
 
o  providing administrative support to the operational expert groups;  

o  working in the area of inspection planning;  

o  general  assistants,  assistants,  supporting  on  procedural  aspects  or  working  on 

document creation. 

Summary of additional resource needs for Medicinal Products Regulation: 

Agency 

Summary of tasks 

EMA 

See above 

Financial resource 
needs: 

Human resource 
needs: 

2024: EUR 0  
2025: EUR 0 
2026: EUR 0 
2027: EUR 0 
2028: EUR 0 
2024:  19 FTE 
2025:  37 FTE 
2026:  52 FTE 
2027:  60 FTE 
2028:  60 FTE 

Future budget line: DG SANTE (EU4Health programme) + EMA fees 

12.  END-OF LIFE VEHICLES (ELV) DIRECTIVE 

Responsible body: 

Currently: Commission with the support of consultants 

(Re-)attribution planned to: ECHA 

Legal basis for reattribution: revision of the Directive on end-of-life vehicles (2000/53/EC) 

Type of task: Existing 

Brief task overview:  

1.  Restriction of hazardous substances in end-of-life vehicles 

2.  Assessments underpinning review of exemptions from restriction on lead, mercury, cadmium, 

or hexavalent chromium.  

Detailed process description: 

Current process: 

The  End-of-life  Vehicle  Directive  bans  the  use  of  four  heavy  metals  (lead,  mercury,  hexavalent 
chromium and cadmium) in vehicles put on the EU market after 1 July 2003. More substances could 
be prohibited, but in practice no substances have been added since the start of the directive. Annex II 
to the Directive lists the exemptions which allow the use of one of these heavy metals in specific 
applications where their use is “unavoidable”. The only criteria used is availability of alternatives. 
Environmental  and  socio-economic  aspects  are  not  considered.  The  Commission  reviews  the 
exemptions on a regular basis based on technical and scientific progress and as the dates of exemption 
validity expire.  

1. Restricting (uses of) hazardous substances in vehicles: (~ REACH restriction): 

•  Has not happened since the initial four heavy metals were placed on Annex II. 

2. Review of exemptions from the restrictions (~ REACH authorisation) 

•  Two years before the expiry date of an exemption, the Commission contracts a consultant to 

105 

 
 
 
 
 
review the existing exemptions. The contractor is used also for new exemptions. Next review 
is in 2025. 

•  Contractor  makes  a  review  of  the  exemption  needs  (example).  The  assessment  focuses  on 
determining whether the use of the substances in applications listed in Annex II is avoidable. 
The assessment includes stakeholder consultation.  

•  Contractor  concludes  on  whether  the  use  of  substances  is  avoidable  and  makes 

recommendation to the Commission.  

•  The  Commission  consults  a  Commission  expert  group  on  the  proposal,  including  MS  and 

stakeholders. 

•  The Commission drafts a delegated act, which is open for a 4-week commenting period, after 

which it adopts the delegated act amending Annex II. 

Changes in the process: Yes 

As part of the revision of the directive, the following changes are envisaged. 

The scope of the Directive will be extended (from passengers’ cars and light commercial vehicles) to 
include  also  motorbikes,  buses,  lorries,  etc.  As  a  result,  higher  workload  is  expected  in  terms  of 
exemption requests.  

Restricting  (uses  of)  new  hazardous  substances  in  vehicles  will  be  done  via  REACH  regulation, 
similarly as proposed for packaging and packaging waste directive.  

ECHA will be tasked to assess the need for exemptions for existing restrictions (4 heavy metals).  

The criteria for exemptions from restriction of 4 heavy metals will be amended to be similar to the 
socio-economic assessment and analysis of alternatives performed under REACH. The only criterion 
currently  used  is  availability  of  alternatives.  Environmental  and  socio-economic  aspects  are  not 
considered.  This  is  criticised,  so  better  alignment  with  assessments  as  done  under  REACH  is 
envisaged.  

Restrictions  of  use  of  chemicals  in  batteries  used  in  vehicles  will  not  be  within  the  scope  of  the 
directive. This is to be addressed under the Batteries Regulation (as lex specialis).  

Proximity to ECHA mandate: All new restrictions of substances in vehicles will be done via the 
restriction  process  under  REACH  and  the  existing  scientific  methodologies  used  for  REACH  
restrictions can be applied. The ELV exemption process will become very similar to the authorisation 
process under REACH, including the criteria for assessment. The substances under scrutiny are the 
same or similar to those under REACH and existing ECHA data and processes can be reused for ELV 
restriction  dossier  development,  exemption  process  and  opinion  forming.  ECHA  holds  the 
appropriate competences to manage the process, however, does not have sufficient information on 
the exact use of substances in end-of-life vehicles.  

Projected synergies and added value of reattribution: 

Type 

Synergies 

Reuse of 
capabilities 

High 

Process and expertise: ECHA already supports similar work on 
substance restrictions and exemptions under REACH and other 
legislation. Several key capacities can be reused/reinforced: 

-  Hazard, risk, exposure and socio-economic assessment 
-  Committee opinion development 
-  Existing IT capabilities for industry dossier submission, 

stakeholder consultation and dissemination 

Re-use of data  Medium  Reuse of data collected under other chemical legislation, but low 

106 

 
 
availability of data on substances in products and waste streams. 

Workload 
balancing 

Medium  With an estimated workload of processing 5 exemption requests 
annually, while developing one new restriction every 5 years, the 
workload of Agency experts and Committee experts can be spread 
and balanced over the years (although resource estimates are 
already annualised). 

High 

IT tools: 
automation 
and economies 
of scale 

Industry actors can submit their exemption requests reusing existing 
ECHA submission tools, at the same time automating the existing 
process. In addition, reuse of IT capabilities for case management, 
public consultation, interaction with Member States, regulatory 
intentions management and data dissemination. 

High 

Support 
services: 
economies of 
scale 

Reuse of scientific support services (e.g. committee secretariat, 
prioritisation and grouping of substances, substance identification, 
data management and dissemination). Reuse of administrative 
services. 

Type 

Added value 

Scientific 
consistency 

High 

Opportunity to align priority setting, timeline, process and 
methodology with other related legislation to improve coherence in 
the scientific advice provided to the Commission. Reuse of data 
collected under other chemical legislation. 

Robustness of 
assessment and 
acceptance 

High 

Insourcing of scientific work from consultants to Agency experts. 
Additional involvement of RAC and SEAC committees adds more 
scientific robustness to the process. 

(See also European Court of Auditors: External consultants at the 
European Commission - Scope for reform). 

Independence  High 

Moving scientific work from consultants to Agency experts and 
committees. ECHA and its committees work under strict conflict of 
interest avoidance rules, improving guarantees of independent 
scientific advice to the Commission. 

Transparency  High 

ECHA’s involvement will bring additional transparency to the 
process: 

-  Overall process transparency 
-  Publication of regulatory intentions of EU authorities 
improves predictability for industry stakeholders 

-  Public consultation/call for evidence 
-  Stakeholder involvement/observer status 
-  Dissemination of scientific data and outcomes 

Main  risks  and  opportunities:  No  major  concerns  and  there  are  certainly  opportunities  to  find 
synergies with the REACH restriction process.  

Projected impact on Agency:  

107 

 
 
 
 
-  ECHA Committees/bodies: medium impact. The task generates medium impact on the setup 

/ organisation / staffing of Committees/bodies due to the additional workload 

RAC 

# of 
opinions 
per year 

rapportuer  Type of 
opinion 

Restriction (as 
part of 
REACH) 

Review of 
exemption  

0 

0 

RAC 
member 

- 

SEAC 

# of 
opinions 
per year 

0 

5 

rapporteur  Type of 
opinion 

SEAC 
member 

SEAC 
member  

-  ECHA  data  model  and  IT  infrastructure:  low  impact.  The  task  can  be  implemented  with 

adjustments / configuration of existing data structures and IT systems 

-  ECHA key experts: medium impact. The task partly relies on existing expert competencies, 
which are limited within ECHA and also critical to REACH/CLP/BPR regulatory tasks 

Projected workload and resource implications:  

Current workload and resource use: 

No new substances were restricted since the adoption of the Directive (end 2000). 4 substances are 
currently restricted. They were restricted as part of the adoption of the legal text end 2000.  

There were 41 valid exemptions in May 2022. The number of exemptions assessed varies across the 
years, with average 2.14 exemption assessment per year:  

11th adaptation 2021 reviewed 

9th and 10th adaptation 2019 

8th adaptation 2016 

7th adaptation 2015 

6th adaptation 2012 

4th and 5th adaptation 2010 

3rd adaptation 2008 

2nd adaptation 2007 

1st adaptation 2004 

Total 

3 exemption requests reviewed 

5 exemptions reviewed 

3 exemptions reviewed 

6 exemptions reviewed 

1 exemption reviewed 

12 exemptions reviewed 

1 new exemption 

11 exemptions reviewed 

5 exemptions reviewed 

47 assessments (average of 2.14 assessments 
annually over 22 years) 

The  Commission  spends  ca.  0,1  FTE  within  DG  ENV  for  the  hazardous  substances  in  the  ELV 
Directive, plus a contract of 60.000 EUR every 2,5 years on average.  

The summary of current resources spent is: 

Ca. 0.1 FTE (dedicated to the work on 

108 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
DG ENV 

DG ENV consultants 

hazardous substances) 

Ca. 0.36 FTE (a contract of EUR 60 000 every 
2.5 years for reviewing exemptions) 

Total 

Ca. 0.46 FTE 

(to convert the cost of consultants into FTEs, the cost of 1 FTE consultant is estimated at ca. EUR 
66 000 annually) 

Such Commission resources do not include contributions to the administrative overhead of the 
Commission (HR, Finance, IT tools, etc.). 

Current budget line: DG Environment 

Future workload and resource needs: 

New restrictions of substances in  vehicles will be done in  the future via  restriction  process  under 
REACH. The number of restrictions can be expected to be approximately 1 restriction per 5 years, 
i.e. 0.2 restriction per year.  

Assessment of the exemptions under the new REACH restriction will be done as part of the REACH 
process and review of REACH restrictions.  

Assessment and review of exemptions from existing restrictions for 4 metals (cadmium, mercury, led 
and chromium VI) will be in the future done by ECHA with involvement of SEAC committee. The 
assessment criteria will be extended as compared to today to be aligned with the criteria used under 
the REACH authorisation process. The scope of the directive will be extended to cover more types 
of vehicles,  which will result in  higher number of  exemption  requests as  compared to today. The 
number  of  assessments  of  exemption  is  expected  to  be  double  as  compared  to  today,  i.e.  4.28 
assessments per year.  

The ELV restriction process is to be similar to REACH restrictions, with an average cost in ECHA 
of 1 (light) – 1.5 (complex) FTE per restriction dossier. The ELV restrictions are expected to be light 
dossiers. 

The exemption review process is assumed similar to REACH applications for authorisations (AfA = 
0.15 (light dossier) – 0.3 (complex dossier) FTE per application. The ELV assessments are expected 
to be light dossiers.  

The resources needed for ECHA are as follow:  

•  Development of 1 restriction dossier every 5 years (scope extension to new vehicle types)+ 
opinion forming: 0.2 FTE (~1 light REACH restriction = 1 FTE). However, considering that 
these restrictions will be performed as REACH restrictions, these resources can be covered 
by the available resources for REACH restriction. Therefore, for this part of work it is 0 FTE. 
•  Review of up to 5 existing exemptions annually + SEAC opinion forming: 0.75 FTE (~unit 

cost of 1 light REACH application for authorisation = 0.15 FTE) 

•  Scientific support services: substance identification and prioritisation, data management and 

• 

dissemination: can be absorbed by the agency  
IT tool development cost (data submission, processing, output): contribution of 15% for 
common components (0.11 FTE) 

•  Horizontal support (governance & enablers / administrative overhead): contribution of 15% 

(0.11 FTE) 

----------- 

109 

 
 
 
Total: 0.97 FTE 

Summary of resource needs for end-of-life vehicle directive: 

Agency 

Summary of tasks 

ECHA 

Preparation of 1 restriction dossier every 5 
years 

Financial resource 
needs: 

Assessment of up to 5 exemptions per year  

Human resource needs: 

2025: EUR 0  
2026: EUR 0 
2027: EUR 0 
2028: EUR 0 
2024:  0 TA, 0 CAs 
2025:  1 TA, 0 CAs 
2026:  1 TA, 0 CAs 
2027:  1 TA, 0 CAs 
2028:  1 TA, 0 CAs 

Future budget line: DG Environment 

Candidate for funding from fees: Task 1 No, Task 2 yes 

13.  TOY SAFETY DIRECTIVE 

Responsible body: 

Currently: Commission with the support of the SCHEER Committee 

(Re-)attribution planned to: ECHA 

Legal basis for reattribution: revision of the Toy safety directive (2009/48/EC). 

Type of task: existing 

Brief task overview:  

1.  Assessment  underpinning  establishing  or  strengthening  chemical  limit  values  in  toys  for 

children under 36 months or toys for other children intended to be taken in the mouth; 

2.  Assessment underpinning amending the limit values for ‘heavy metals’ in toys;  

3.  Assessment underpinning amendments to the lists of allergenic fragrances that are prohibited 

in toys or that have to be labelled if present in toys;  

4.  Assessment underpinning a derogation for the use of CMR substances in toys.  

Detailed process description: 

Current process: 

Tasks 1, 2 and 3: 

The process can be triggered by an expert of the subgroup Chemicals (which is a subgroup of  the 
Expert Group on Toys Safety  (01360) consisting of experts from the Member States, EEA-EFTA 
countries, the toy industry, the European consumer organisations ANEC) suggesting that  a new or 
strengthened  limit  value  for  a  chemical  substance  is  needed,  for  example  due  to  new  scientific 
knowledge.  Also  a  Scientific  Committee  opinion,  such  as  from  the  Scientific  Committee  on 
Consumer Safety (SCCS), may be a basis for the Commission services to propose a new/strengthened 
limit value; 

Once  the  process  is  triggered,  the  subgroup  Chemicals  discusses  the  possible  occurrence  of  the 
substance in toys, assesses the hazard, exposure and risk and recommends a limit value for toys below 
which the substance presents no risk. In case of conflicting views in the subgroup Chemicals that 

110 

 
 
 
 
 
 
cannot be resolved, the Commission asks the Scientific Committee on Health, Environmental and 
Emerging Risks (SCHEER) to assess the hazard, exposure and risk, and to recommend a limit value 
for toys that presents no risk.  

On the basis of the above recommendation, the Commission services draft a Directive amending the 
Toy Safety Directive, Appendix C. The draft Directive indicates in its recitals the occurrence of the 
chemical  substance  and  suggests  test  methods  for  the  substance  in  toys  and  toy  materials.  The 
Commission consults the proposal with the Expert Group on Toy Safety (consisting of experts from 
the  Member  States,  EEA-EFTA  countries,  Candidate  Countries,  Switzerland,  the  toy  industry, 
European  consumer  organisations  (ANEC,  BEUC),  CEN,  Cenelec,  notified  bodies).  After  the 
consultation, the Commission adopts the proposal via the comitology procedure.  

Task 4: 

The  process  is  usually  triggered  by  a  toy  industry  expert,  suggesting  a  derogation  to  allow  the 
continued use of a CMR substance (Cat. 1A, 1B or 2) in toys. This occurs when a substance has been 
newly classified as being CMR.  

The subgroup Chemicals briefly discusses the derogation and the Commission services requests the 
toy industry for an analysis of alternatives in the case substance is a CMR cat 1 A or 1B ( no analysis 
is necessaryif the substance is Cat. 2).  

The Commission services then mandate the SCHEER to assess the use of the CMR substance in toys. 
To allow the Commission to grant a derogation, the SCHEER has to assess the use of the CMR in 
toys as safe. The Commission services also check whether REACH does not prohibited the CMR 
substance in consumer articles.  

If the use of the CMR substance in toys is concluded by SCHEER to be safe, there is no prohibition 
of the substance in the consumer articles under REACH and the industry provides the analusis of 
alternatives  when  necessary,  the  Commission  services  draft  a  Directive  amending  the  Toy  Safety 
Directive, Appendix  A. Then the Commission  consults  with the Expert Group on Toy  Safety  and 
adopts the proposal. 

Changes envisaged as part of reattribution: Yes 

With the revision, the Commission intends to introduce the following changes: 

• 

• 

extending the generic assessment  approach (automatic ban) to  other hazard classes for the 
most harmful chemicals such as endocrine disrupting chemicals;  

the possibility to introduce specific limit values for new chemicals could be introduced in all 
toys, and not only in toys intended for children under 36 months or to be put in the mouth, as 
is the case today. 

•  Transfer the risk assessment tasks from SCHEER committee to ECHA’s Committee for Risk 

Assessment (RAC). 

Proximity to ECHA mandate: The task is closely related to ECHA’s core mandate and ECHA has 
the needed data, competences and expertise to perform the task. 

Projected synergies and added value of reattribution: 

Type 

Synergies 

Reuse of 
capabilities 

High 

Process and expertise: ECHA already performs similar work on 
restrictions, derogations, setting of limit values and assessing socio-
economic impacts under REACH and other legislation. Several key 

111 

 
 
capacities can be reused/reinforced: 

-  Hazard, risk, exposure and socio-economic assessment 
-  Exposure limit value definition 
-  Committee opinion development 
-  Existing IT capabilities for industry dossier submission, 

stakeholder consultation and dissemination 

Re-use of data  High 

Reuse of data collected under other chemical legislation, especially 
REACH & CLP and via the SCIP database, with a focus on CMRs 
and Endocrine Disruptors. 

Workload 
balancing 

Medium  With an estimated workload of 2 derogation requests and setting 
limit values for 2 additional substances annually, the workload of 
Agency experts and Committee experts can be spread and balanced 
over the years (although resource estimates are already annualised). 

High 

IT tools: 
automation 
and economies 
of scale 

Industry actors can submit their derogation requests reusing existing 
ECHA submission tools, at the same time automating the existing 
process. In addition, reuse of IT capabilities for case management, 
public consultation, interaction with Member States, regulatory 
intentions management and data dissemination. 

High 

Support 
services: 
economies of 
scale 

Reuse of scientific support services (e.g. committee secretariat, 
prioritisation and grouping of substances, substance identification, 
data management and dissemination). Reuse of administrative 
services. 

Type 

Added value 

Scientific 
consistency 

High 

Opportunity to align priority setting, timeline, process and 
methodology with other related legislation. Reuse of data collected 
under other chemical legislation to improve coherence in the 
scientific advice provided to the Commission. 

Robustness of 
assessment and 
acceptance 

High 

Independence  High 

Insourcing of scientific work from consultants to Agency experts. 
Centralising the scientific committees for assessing chemicals in 
one EU agency and stricter separation between policy and scientific 
advice adds more scientific robustness to the process. 

(See also European Court of Auditors: External consultants at the 
European Commission - Scope for reform). 

Moving scientific work from consultants to Agency experts and 
from dispersed Commission committees to well-established 
committees in the European Chemicals Agency with a stricter 
separation between science and policy. ECHA and its committees 
work under stricter conflict of interest avoidance rules, improving 
guarantees of independent scientific advice to the Commission. 

Transparency  High 

ECHA’s involvement will bring additional transparency to the 
process: 

112 

 
 
 
-  Overall process transparency 
-  Publication of regulatory intentions of EU authorities 
improves predictability for industry stakeholders 

-  Public consultation/call for evidence 
-  Stakeholder involvement/observer status 
-  Dissemination of scientific data and outcomes 

Main risks and opportunities: Methodologies would need to be aligned. Finally, the revision is an 
opportunity to also streamline the process and align with similar processes under REACH. 

Projected impact on ECHA: 

•  ECHA Committees/bodies: high impact. The task generates major impact on the setup / 

organisation / staffing of Committees/bodies due to the additional workload 

RAC 

# of 
opinions 
per year 

4.2 

rapporteur  Type of 
opinion 

RAC 
member 

SEAC 

# of 
opinions 
per year 

4.2 

rapporteur  Type of 
opinion 

SEAC 
member 

Assessments 
under Tasks 
1,2,3 or 4 

•  ECHA data model and IT infrastructure: low impact. The task can be implemented with 

adjustments / configuration of existing data structures and IT systems 

•  ECHA key experts: high impact. The task heavily relies on expert competencies, which are 

limited within ECHA and also critical to REACH/CLP/BPR regulatory tasks 

Projected workload and resource implications:  

Current workload and resource use:  

In 12 years (2010-2021), there were 10 opinions requested from SCHEER (and before from SCHER 
and SCENIHR). These opinions were about 17 substances and dealt with setting or reviewing limit 
values (3 opinions for 13 substances), 2 generic assessments and 2 derogations requests:  

-  2021: limit values for 8 substances in squishy toys 
-  2017: limit value for 1 substance 
-  2016: 1 generic opinion 
-  2015: limit value for 1 substance 
-  2012: 3 opinions (including 2 limit values and 1 derogation) 
-  2010: 3 opinions (including 1 limit value and 1 derogation request) 

The secretariat of the scientific committees hosted by DG SANTE employs 4 FTE of DG SANTE 
and 2 additional FTEs of external interim staff (for technical and administrative support like literature 
search,  editing  and  proofreading  of  opinions,  website  mastering,  assistance  for  the  Health-EU 
newsletter, dissemination activities). The staff of 6 FTEs is equally split over two committees, which 
means that 3 FTEs are used to support work of SCHEER. The workload of SCHEER dedicated to 
support of toys safety directive amounts to 10% of its time, which makes 0.3 FTE.  

The operational costs for two committees (that includes special indemnities, accommodation, daily 
allowances, travel costs, reimbursement for rapporteurship, etc) operated by the Commission were 
EUR 2 883 030 for 6 years (2016-2021), which makes it approximately EUR 240 000 per year per 
committee. It must be noted that the operational costs in 2019 were EUR 340 000, which then went 
down because of the pandemic measures. The workload of SCHEER dedicated to support of toys 
113 

 
 
 
 
 
 
 
 
 
 
safety directive amounts to 10% of its time, which corresponds to operational costs of EUR 24 000 
(or at higher level of 2019 to EUR 34 000).  

The resource use can be summarized as follows:  
DG GROW 

DG SANTE SCHEER secretariat 

Ca. 1 FTE (dedicated to the work on hazardous 
substances) 

Ca. 0.3 FTE (10% of workload of SCHEER 
secretariat) 

SCHEER committee 

10% of membership capacity 

Total 

Ca. 1.3 FTE 

Operation costs EUR 24 000/ year 

(to convert the cost of consultants into FTEs, the cost of 1 FTE consultant is estimated at ca. EUR 
66 000 annually) 

Such  Commission  resources  do  not  include  contributions  to  the  administrative  overhead  of  the 
Commission (HR, Finance, IT tools, etc.). 

Future workload and resource needs: 

With the revision, the Commission intends to introduce the following changes: 

• 

• 

extending the generic assessment approach (automatic ban) to endocrine disrupting 
chemicals;  

the possibility to introduce specific limit values for new chemicals could be introduced in all 
toys, and not only in toys intended for children under 36 months or to be put in the mouth, 
as is the case today. 

Furthermore, currently CMRs are still allowed in toys up to the relevant CLP concentration limits. 
Beyond those, derogations can be requested. Only a few derogations were requested by industry in 
the past.  If the generic prohibition  would be extended from  CMRs to  EDC (or maybe even other 
hazard classes), then also new derogation requests could be expected, especially in the early years 
when production processes have not yet been adapted and EDCs are still present in potentially quite 
large  amounts.  Due  to  this,  it  can  be  reasonably  expected  that  the  workload  for  derogations  will 
multiply (assumption x10 in the first years), but still within reasonable limits (e.g. 2 requests annually 
vs 2 requests in 10-12 years). 

The main work related to limit value setting can be best compared to CLH work, which is currently 
rated at 0.5 FTE per substance per year within ECHA. 

The processing of derogation requests is assumed similar to REACH applications for authorisations 
(AfA = 0.15 – 0.3 FTE / application). 

The resource needs for ECHA would then be as follow: 

•  Setting/reviewing limit values for 2 substances every year + scientific committee opinion 

forming: 1.0 FTE annually (~unit cost of 1 CLH opinion = 0.5 FTE) 

•  Restriction/prohibition of 1 substance or generic opinion development for 1 

substance/subject every 5 years + scientific committee opinion forming: 0.3 FTE annually 
(~unit cost of 1 REACH restriction = 1 – 1.5 FTE) 

•  Review of 2 derogation requests annually + scientific committee opinion forming: 0.3 FTE 

(~unit cost of 1 REACH application for authorisation = 0.15 – 0.3 FTE) 

114 

 
 
•  Scientific support services: substance identification and prioritisation, data management and 

• 

dissemination: can be absorbed by the agency 
IT tool development cost (data submission, processing, output): contribution of 15% for 
common components (0.24 FTE) 

•  Horizontal support (governance & enablers / administrative overhead): contribution of 15% 

(0.26 FTE) 

----------- 

Total: 2 FTEs 

Summary of resource needs for toy safety directive: 

Agency 

Summary of tasks 

ECHA 

Assessment underpinning chemical limit values  

Assessment  underpinning  amending  the  limit 
values for ‘heavy metals’ in toys;  

Assessment underpinning amendments to the lists 
of allergenic fragrances that are prohibited in toys  

Assessment underpinning a derogation for the use 
of CMR and EDs substances in toys. 

Future budget line: DG GROW 

Candidate for fees: No 

Financial resource 
needs: 

Human resource 
needs: 

2024: EUR 0  
2025: EUR 0 
2026: EUR 0 
2027: EUR 0 
2028: EUR 0 
2024:  0 TAs, 0 CAs 
2025:  2 TAs, 0 CAs 
2026:  2 TAs, 0 CAs 
2027:  2 TAs, 0 CAs 
2028:  2 TAs, 0 CAs 

14.  RESTRICTION OF HAZARDOUS SUBSTANCE (ROHS) DIRECTIVE (2011/65/EU) 

Responsible body: 

Currently: Commission with the support of consultants 

(Re-)attribution planned to: ECHA 

Legal basis for reattribution:  Directive amending the RoHS Directive on reattribution of tasks to 
ECHA 

Type of task: Existing 

Brief task overview:  

1.  Assessments  underpinning  restrictions  of  hazardous  substances  in  electrical  and  electronic 

equipment (currently 10 restricted substances)  

2.  Review of applications for exemptions from the restrictions.  

Detailed process description: 

Current process: 

RoHS  restricts  the  use  of  hazardous  substances  in  Electrical  and  Electronic  Equipment  (EEE).  It 
covers the placing on the market of articles. It does not cover the use of the substance during the 
manufacture of them. The restricted substances are included in Annex II to the Directive. They are 
identified in accordance with the criteria outlined in its Article 6(1) with priority given to substances 
included  in  Annexes  XIV  or  XVII  to  REACH,  Substances  of  Very  High  Concern  (SVHC)  and 
substances  with  detrimental  effects  on  waste  management.  RoHS  includes  also  provisions  for 
granting  temporary  exemptions  for  specific  applications  under  certain  conditions  pursuant  to 

115 

 
 
 
 
 
Article 5. Applications exempted from the restrictions are included in Annex III and IV. The details 
of the processes are: 

1.  Restricting  hazardous  substances  in  electrical  and  electronic  equipment (similar  to  REACH 
restriction): 

•  The process is initiated by the Commission on its own initiative or following submission of 

a proposal by MSs (Art 6(1)). 

•  Consultants perform a prioritisation to select substances. 
•  Consultants perform an in-depth assessment (determination of hazard profile + waste 

management issues + also some basic socio-economic assessment; it includes consultation 
of interested parties). 

•  Consultants make a recommendation whether the substance should be listed. 
•  The Commission drafts delegated act modifying Annex II (currently listing 10 substances 

with their maximum concentration values). 

2. Reviewing exemptions from the restrictions (similar to REACH authorisation) 

• 

Industry applies for the exemption (new, renewal or revocation). Exemptions are by 
technical application. 

•  Consultants evaluate the request for derogation and its justification vis-à-vis the conditions 

provided in Article 5(1)(a). It includes consultation of interested parties. 

•  Consultants make recommendation whether a derogation shall be granted (and for how 

long). 

•  The Commission adopts a delegated act modifying the Annexes III or IV. 

Changes envisaged as part of reattribution: Yes 

The Commission wishes to establish a Registry of intentions. It also wishes to address the current 
criticism on the process with regard to lack of transparency, predictability of duration of the processes 
and  of  the  procedural  steps,  involvement  of  stakeholders,  quality  of  the  assessment  process  and 
required time. Alignment with other chemicals legislation is also desired. 

Proximity to agency’s mandate: The RoHS restriction process, although not identical, is similar to 
the REACH restriction process and the similar scientific methodologies can be applied. The RoHS 
exemption process, although not the same, resembles the authorisation process under REACH. The 
substances under scrutiny are the same or similar to those under REACH and existing ECHA data 
and  processes  can  be  reused  for  RoHS  restriction  dossier  development,  exemption  process  and 
opinion forming. ECHA holds the right competences to manage the process, however, does not yet 
have sufficient information on the exact use of substances in electronic equipment.  

Projected synergies and added value of reattribution: 

Type 

Synergies 

Reuse of 
capabilities 

High 

Process  and  expertise:  ECHA  already  supports  similar  work  on 
substance  restrictions  and  exemptions  under  REACH  and  other 
legislation. Several key capacities can be reused/reinforced: 

-  Hazard, risk, exposure and socio-economic assessment 
-  Committee opinion development 
-  Existing  IT  capabilities  for  industry  dossier  submission, 

stakeholder consultation and dissemination 

Re-use of 
data 

Medium  Reuse  of  substance  identification  and  hazard  data  collected  under 
other  chemical  legislation.  Currently  low  availability  of  data  on 

116 

 
 
 
substances in products and waste streams. 

Workload 
balancing 

Low 

With  an  estimated  workload  of  processing  27  exemption  requests 
annually,  while  assessing  one  substance  every  year  for  the  list  of 
restricted substances, there is little room for workload balancing (and 
resource estimates are already annualised). 

High 

High 

IT tools: 
automation 
and 
economies of 
scale 

Support 
services: 
economies of 
scale 

Industry actors can submit their exemption requests reusing existing 
ECHA  submission  tools,  at  the  same  time  automating  the  existing 
process.  In  addition,  reuse  of  IT  capabilities  for  case  management, 
public  consultation,  interaction  with  Member  States,  regulatory 
intentions management and data dissemination. 

Reuse  of  scientific  support  services  (e.g.  committee  secretariat, 
prioritisation  and  grouping  of  substances,  substance  identification, 
data  management  and  dissemination).  Reuse  of  administrative 
services. 

Type 

Added value 

Scientific 
consistency 

High 

to  align  priority  setting, 

Opportunity 
timeline,  process  and 
methodology with other related legislation to improve coherence in 
the  scientific  advice  provided  to  the  Commission.  Reuse  of 
assessment insights developed under other chemical legislation. 

Robustness  of 
assessment  and 
acceptance 

High 

Insourcing  of  scientific  work  from  consultants  to  Agency  experts. 
Additional involvement of RAC and SEAC committees adds more 
scientific robustness to the process. 

(See also European Court of Auditors: External consultants at the 
European Commission - Scope for reform). 

Independence  High 

Moving  scientific  work  from  consultants  to  Agency  experts  and 
committees. ECHA and its committees work under strict conflict of 
interest  avoidance  rules,  improving  guarantees  of  independent 
scientific advice to the Commission. 

Transparency  High 

ECHA’s  involvement  will  bring  additional  transparency  to  the 
process: 

-  Overall process transparency 
-  Publication  of  regulatory  intentions  of  EU  authorities 

improves predictability for industry stakeholders 

-  Public consultation/call for evidence 
-  Stakeholder involvement/observer status 
-  Dissemination of scientific data and outcomes 

Main  risks  and  opportunities:    No  major  concerns  and  there  are  certainly  opportunities  to  find 
synergies with the REACH restriction/authorisation process.  

Projected impact on agencies:  

-  ECHA  Committees/bodies:  high  impact.  The  task  generates  major  impact  on  the  setup  / 
organisation / staffing of Committees/bodies due to the additional workload. The major impact 
117 

 
 
 
 
is on SEAC committee.  

RAC 

# of 
opinions 
per year 

rapporteur  Type of 
opinion 

Restriction  

Exemptions 

1 

3 

RAC 
member 

RAC 
member  

SEAC 

# of 
opinions 
per year 

1 

30 

rapporteur  Type of 
opinion 

SEAC 
member 

SEAC 
member  

-  ECHA data model and IT infrastructure: low impact. The task can be implemented with 

adjustments / configuration of existing data structures and IT systems 

-  ECHA key experts: high impact. The task heavily relies on expert competencies, which are 
limited within ECHA and also critical to REACH/CLP/BPR regulatory tasks. The end of life 
of an electrical and electronic equipment is important in this work and the expertise will 
need to be built in this area.  

Projected workload and resource implications: 

Current workload and resource use: 

Currently,  there  are  10  restricted  substances.  When  the  first  directive  was  adopted  in  2003, 
6 substances  were  restricted.  The  2011  revision  of  the  directive  introduced  an  obligation  on  the 
Commission  to  review  and  amend  the  list  of  restricted  substances  at  the  latest  by  July  2014  and 
periodically thereafter. In the first review, the Commission with the help of a consultant assessed 5 
substances out of which four were added to the list of restricted substances in 2015 (Recital 10). The 
second  review  was  launched  in  2018  and  assessed  7  substances  (/groups),  out  of  which  2  were 
recommended to be restricted. They have not been added to the list yet, as for one substance there is 
an  assessment  undergoing  under  the  Stockholm  Convention.    Based  on  this  information  (12 
substances  (/groups)  assessed  in  12  years  (2011  -  2023)),  the  current  average  workload  can  be 
estimated to be as 1 assessment of a chemical per year. 

The second review which assessed 7 substances was supported by an external consultant contracted 
by DG ENV. The cost of the contract was ca. EUR 180 000 and it took 2 years. As the assessments 
are to be done ca. every 5 years, this indicates the current resources used for external support to be 
approximately 2.7 FTEs (EUR 180 000/66 000) for 7 substances for 5 years, i.e. 0.54 FTE annually.  

There are 45 time-limited use exemptions (Annex III) and 48 exempted uses in medical devices or 
monitoring  and  control  instruments  (Annex  IV)  as  current  number  entries.  Each  number  entry 
however can cover several final applications, which can be categorised in different EEE categories 
(Annex I). Depending on the expiry date, exemptions can have up to four sub-entries for four groups 
of categories. By including these sub-entries, there are 238 valid exemptions (Status March 2023). In 
addition, a handful of exemption requests were assessed but no exemption was granted due to failure 
to meet the criteria.  

The  number  of  completed  exemption  evaluations,  resulting  in  a  published  report,  and  the 
corresponding amount of resources required for external support varied depending on the year (see 
table below). Due to expiry dates of existing exemptions, there are many applications and evaluations 
in  certain  years.  On  average,  in  the  period  between  2015  and  2022,  there  were  13.9  exemptions 
evaluated per year. 

2015 

2016 

2017 

2018 

2019 

2020 

2021 

2022 

118 

 
 
 
 
 
 
 
 
 
 
 
 
 
Number of exemptions 
evaluated (date of 
publication of study) 

2 

38 

4 

11 

2 

9 

0 

45 

The number and complexity of exemptions requests increased over the years and it created a backlog 
on  evaluating  exemption  request  and  adopting  respective  individual  delegated  directives.  The 
corresponding resources spent for external support for assessments of exemption requests in the years 
2017-2022  were  ca.  EUR  145  000  per  year  (on  average),  or  ca.  EUR  12  000  per  exemption 
assessment, or 2.2 FTEs per year (EUR 145 000/66 000) or 0.18 FTE per exemption assessment (EUR 
12 000/66 000).  

The current resources spent by the Commission can be summarized as follows:  

DG ENV (for overall RoHS implementation) 

DG ENV consultants – support for restrictions 

Ca. 1.5 FTE (on average) 

Ca. 0.54 FTE annually (a contract of EUR 180 000 on 
average each 5 years for reviewing restrictions) 

DG ENV consultants – support for exemption evaluation   Ca. 2.2 FTE annually (contract for EUR 145 000 

annually (average from 2017-2022) for outsourcing the 
technical evaluation of exemption requests) 

(to convert the cost of consultants into FTEs, the cost of 1 FTE consultant is estimated at ca. EUR 
66 000 annually) 

It  must  be  noted  that  these  resource  estimates  do  not  include  contributions  to  the  administrative 
overhead of the Commission (HR, Finance, IT tools, etc.). It must be also noted that the resources 
spent by the Commission were not sufficient, leading to the accumulation of requests for exemptions 
without processing them to the legal drafting (currently 61 exemptions pending) and the revision of 
the restriction was delayed (the review not finalised although it has started in 2018). There were also 
complaints about the quality and robustness of the assessments, the transparency of the process and 
involvement of stakeholders.  

Current budget line: DG Environment   

Future workload and resource needs: 

Restrictions can be proposed by Member States and Commission has a duty to periodically review 
the  list  of  restricted  substances.  It  is  expected  that  the  number  of  restrictions  and  underlying 
assessments will be the same as in the past, i.e. assessment of ca. 1 chemical per year.  

Requests  for  exemptions  are  submitted  by  industry.  As  exemptions  are  time-bound,  the  workload 
volume is determined by the number of exemptions already in place and new requests coming in. 
When a new restriction is introduced, it leads temporarily to higher number of requests.  

In the near future it is expected that the number of exemption requests will increase as compared to 
the past because in the past one exemption, which can be relevant for different final applications, had 
one expiry date regardless of their final application (e.g. in medical devices). With the introduction 
of splitting exemption entries depending on their final application, one previous exemption entry can 
have  now  several  different  expiry  dates.  That  means,  the  number  of  exemption  requests  can  be 
multiplied provided there are different final applications and the industry is applying for renewal. In 
addition, in order to narrow down the scope of exemptions, exemptions are more and more split in 

119 

 
 
 
 
 
 
more specified sub-exemptions, which should narrow down the covered applications and allow more 
specific decisions.  

Not all exemptions are applied for renewal, but economic operators can submit also new exemption 
requests. It is expected that in the period of 2024-2025 there will be ca. 30 exemption requests per 
year  to  be  evaluated  –  provided  recommended  exemptions  with  respective  expiry  date  will  be 
included. 

For the future, the Commission (and stakeholders) also wishes to improve the procedure as regards 
transparency (establishment of a registry of intent), involvement of stakeholders, the level of scrutiny 
by the experts, robustness of the advice, independence of the advice and ensuring coherence with the 
assessments performed under the other pieces of legislation. This will increase the need for resources 
per  exemption  as  compared  to  the  past,  but  it  is  inevitable  to  address  the  concerns  raised  by  the 
stakeholders and to ensure robustness and acceptance of the process.  

To evaluate specific exemption requests, ECHA might still require external expertise from time to 
time (e.g. for assessing specific information about electronics). At the beginning, the need for external 
expertise may occur more frequently than at a later stage when experience has already been gained 
(e.g. with  re-occurring renewal  requests). However, it is  expected that consulting external  experts 
remains the exception. In addition, there will be a need to implement the procedure (e.g. by updating 
the guidance document for applications for an exemption). These irregular tasks depend on needs at 
that specific moment and they are predestined to be carried out by external consultants. In order to 
allow such ad-hoc tasks in the future, an operational budget is needed.  

The future RoHS restriction process is assumed to be similar to REACH restrictions, with an average 
cost in ECHA of 1 (light dossier) – 1.5 (complex dossier) FTE / restriction dossier. As it is expected 
that in average there will be a need for 1 restriction dossier per year and the restriction dossiers will 
be likely light, it is estimated that there would be a need for additional 1 FTE per year.  

The future process for assessing exemption requests is assumed to be similar to REACH applications 
for  authorisations  (~  AfA  =  0.15  (light  dossier)  –  0.3  (complex  dossier)  FTE  /  application).  It  is 
expected that the RoHS exemption assessments are to require light assessment, thus 0.15 FTE per 
application. In addition, it is expected that RAC is consulted in 10% of the exemption applications 
and the work is estimated with 0.1 FTE per exemption. However, this additional resources for RAC 
can be absorbed by the Agency as part of the synergies with other work. In combination with the 
average of expected exemption requests (i.e. 30 exemptions per year), this would result in 4.5 FTEs 
per year.  

The following resource estimates correspond to the “ECHA way”, i.e. implementing similar processes 
and similar level of digitalisation to what is in place for ECHA’s current tasks. Such examples would 
be the creation of registries of intentions and the dissemination of lists (exemptions, restrictions) as 
structured data.  

•  Development of 1 restriction dossier annually + opinion forming by RAC and SEAC: 1 

FTE (~ unit cost of 1 REACH restriction = 1 (light) to 1.5 FTE (complex)) 

•  Review of 30 exemption applications annually + opinion forming of SEAC and for 10% of 

cases also by RAC: 4.5 FTEs  

• 

•  Scientific support services: substance identification and prioritisation of candidate 
substances, data management and dissemination: to be absorbed by the Agency 
IT tool development cost (industry and authority data submission, processing, output): 
contribution of 15% for development and maintenance of common components (0.8 FTE) 
•  Horizontal support (governance & enablers / administrative overhead): contribution of 15% 

(0.8 FTE) 

•  Add-hoc support by external consultants (e.g. specific expertise): EUR 66 000 in the first 

120 

 
 
year and EUR 33 000 in average in the following years. 

Estimated workload 
volume 

ECHA resource need 

1 additional 
restriction per year 

7 FTEs  

(including IT tool development 
and administrative overhead) 

30 exemption 
requests / year 

Process 

Tasks 

Restriction of 
substances in 
electronic 
appliances 

Exemption 
requests 

-  Substance prioritisation and 

data analytics 
-  Restriction dossier 

development (ECHA 
secretariat) 

-  Conformity check 
-  Public/targeted consultation 
-  Committee opinion 

development (incl. support by 
secretariat) 

Industry dossier intake 

-  Data dissemination 
- 
-  Completeness check 
-  Public consultation 
-  Committee opinion 

development (incl. support by 
secretariat) 

-  Support COM during 
adoption of the IA 
-  Data dissemination 

Summary of additional resource needs for restriction of hazardous substances (RoHS) directive: 

Agency 

ECHA 

Summary of tasks 

Resource needs 

- restriction of substances in electronic and 
electrical equipment (ca. 1 dossier per year) 

Financial resource 
needs: 

- assessment of exemption request (30 
assessments per year) 

Human resource 
needs: 

2024: EUR 0 
2025: EUR 66 000  
2026: EUR 33 000 
2027: EUR 33 000 
2028: EUR 33 000 
2024:  0 TA, 0 CA 
2025:  3 TA, 0 CA 
2026:  4 TA, 3 CA 
2027:  4 TA, 3 CA 
2028:  4 TA, 3 CA 

Future budget line: DG Environment  

Candidate for fees: Yes, for assessment of exemptions 

15.  POPS REGULATION (2019/1021) 

Responsible body: 

Currently: Commission with the support of consultants 

(Re-)attribution planned to: ECHA, EEA 

Legal basis for reattribution: Omnibus regulation for reattribution of tasks 

Type of task: existing 

Brief task overview:  

1.  Assessments  underpinning  setting  concentration  limit  values  for  substances  subject  to  waste 

121 

 
 
 
 
 
 
management provisions as part of the review of Annexes IV and V of the POPs regulation 

2.  Receiving  chemical  monitoring  data  of  POPs  as  part  of  the  regular  reporting  under  the  POPs 

regulation  

Detailed process description: 

Current process: 

Task 1 

For a substance added to Annex I (prohibition on manufacturing, placing on the market  and use), 
Annex II (list of substances subject to restrictions) and as appropriate also for substances in Annex 
III  (list of substances subject to release reduction provisions), limit values in Annex IV and V for 
these  substances  contained  in  waste  need  to  be  set,  in  order  to  ensure  the  environmentally  sound 
management of waste consisting of or contaminated by this POP substance. 

The concentration limit values set for waste containing POP substances directly affects the amounts 
of the concerned waste stream that can potentially be recycled, rather than being disposed of; a stricter 
limit value could even result in the cessation of recycling of the waste stream altogether. These limits 
are  also  very  important  in  determing  the  possible  disposal  routes  for  waste  (e.g.  disposal  in  non-
hazardous  or  hazardous  waste  landfills  instead  of  incineration,  admission  in  different  types  of 
incineration  or  co-incineration  facilities.  All  these  have  relevant  economic  consequences  for 
operators. 

Two concentration limits are distinguished for POPs in waste: 

•  Low  POP  concentration  limit  (Annex  IV):  defines  the  concentration  limit  above  which  POPs 
content in waste shall be subject to destruction or irreversible transformation; this means the waste 
cannot be recycled and disposal options are limited to certain treatments (possible exceptions can 
be granted by Member States for certain wastes)  

•  Maximum POP concentration limit (Annex V): defines the threshold above which no derogation 

from the obligation to destroy or irreversibly transform the POP content can be granted 

The need to act is triggered by inclusion of a substance in the Stockholm Convention, following which 
the process is initiated by the Commission: approx. 2-3 substances are identified as POPs under the 
Stockholm  Convention  every  2  years,  but  for  the  transposition  into  the  POPs  Regulation  the 
Commission acts in five year cycles due to the heavy ordinary legislative procedure to add substances 
to Annexes IV and V of the POPs Regulation. 

For existing limit values in Annex IV and V no standard review process exists, but the values need 
to be kept up to date in view of scientific and technical progress and revision clauses contained in the 
Regulation, for substances already listed, need to be observed. 

Under the current practice, consultants perform a technical assessment (hazard, risk, socioeconomic 
aspects) for setting concentration limit values of the substance(s) in waste. This includes: 

•  Collection of data on hazard and risk of the substance: this is mostly taken from the Stockholm 

Convention listing exercise of the substance; 

•  Compilation of information for identification of presence and concentrations of the substance in 
different  waste streams,  and on recycling and other waste treatment  activities involving  waste 
containing this substance(s), followed by an analysis of the information. Starting from reported 
uses of this substance in products and articles and their material flows this  includes a targeted 
stakeholder  consultation  (Member  States  and  other  relevant  stakeholders  in  particular  waste 
operators and users of recycled materials) 

•  Application of an existing risk assessment methodology plus a socio economic assessment (no 
full socio-economic impact assessment) already developed by a consultant and applied in the past 

122 

 
 
(not legally binding) regarding the implications on waste management of possible limit values for 
the substance in Annexes IV and V: different secenarios for delimination of the concentration 
range  for  a  limit  value  are  developed  based  on  the  application  of  lower  and  upper  limitation 
criteria: 

-  Lower limitation criteria: 

▪  Limit values must be controlable analytically, 
▪  Limit values should be above existing environmental background 

contaminations, 
the new required capacities for waste recovery and disposal are realistically 
available, and 
required additional waste management costs are economically reasonable 

▪ 

▪ 

-  Upper limitation criteria: 

▪  Limit values should not conflict with existing limit values 
▪  Avoidance of adverse effects on HH (general population plus workers) and ENV  
•  Based  on  the  analysis  of  the  impacts  for  different  options  of  the  limit  values  provided  by  the 
contractor, the Commission (DG ENV) develops an impact assessment for the options of the limit 
values  and  decides  on  the  preffered  option.  The  impact  assessemnt  is  scrutinised  by  the 
Regulatory Scrutiny Board; 

•  After the positive opinion of the regulatory scrutiny board, the Commission makes a proposal for 

amendment of Annexes IV or V 

•  The  proposal  is  submitted  to  the  ordinary  legislative  procedure  that  is  followed  from  the 

Commission side by DG ENV.  

Task 2 

Article 10 requires the Commission, supported by ECHA, and Member States to establish or maintain, 
as appropriate, in close cooperation, appropriate programmes and mechanisms, consistent with the 
state of the art, for the regular provision of comparable monitoring data on the presence of substances 
as  listed  in  Part  A  of  Annex  III  in  the  environment.  When  establishing  or  maintaining  such 
programmes and mechanisms, due account shall be taken of developments under the Protocol and the 
Convention.  The  Commission  is  also  mandated  to  regularly  assess  the  possible  need  for  the 
mandatory  monitoring  of  a  substance  listed  in  Part  B  of  Annex  III  and  empowered  to  move  a 
substance form Part B of Annex III to Part A. 

Annex  III  Part  A  currently  contains  polychlorinated  dibenzo-p-dioxins  and  dibenzofurans 
(PCDD/PCDF) and polychlorinated biphenyls (PCB). Part B currently contains hexachlorobenzene, 
polycyclic  aromatic  hydrocarbons,  pentachlorobenzene,  hezachlorobutadiene  and  polychlorinated 
naphthalenes.  

Article 13(1)(e) requires Member States to draw up and publish a report containing information on 
the presence of substances listed in Part A of Annex III in the environment, as compiled pursuant to 
Article 10.  

Article  13(2)  states  that  where  a  Member  State  shares  the  information  referred  to  in  point  (e)  of 
paragraph 1 with the Information Platform for Chemical Monitoring, this shall be indicated by that 
Member State in its report and the Member State shall be considered to have fulfilled its reporting 
obligations under that point. Where the information referred to in point (e) of paragraph 1 is contained 
in the report of a Member State provided to ECHA, ECHA shall use the Information Platform for 
Chemical Monitoring for compiling, storing and sharing that information. 

Changes in the process: Yes 

Task 1 
• 

It  is  expected  that  ECHA  prepares  a  report  with  a  technical  assessment  (hazard,  risk, 

123 

 
 
socioeconomic aspects)  for setting  concentration limit  values of the substance(s) in  waste and 
makes a proposal for the concentration limit values. 

•  Some detailed elements of the exising risk and socio-economic assessment methodology  used so 
far,  especially  as  regards  risk  assessment  used  to  determine  upper  limitation  criteir  based  on 
human  and  environmental  health  impacts,  may  need  to  be  critically  assessed  and  updated  by 
ECHA. 
It  is  expected  that  ECHA’s  Committee  for  Socio-Economic  Assessment  (SEAC)  provides  an 
opinion  on  the  report  prepared  by  ECHA  and  on  the  concentration  limit  values  proposed  by 
ECHA.  

• 

•  The  report  and  the  opinion  of  SEAC  is  then  transmitted  by  ECHA  to  the  Commission.  If 
significant divergence exists between the ECHA report and the SEAC opinion, ECHA submits to 
the Commission an explanation of the divergence.  

•  Based on the ECHA report and SEAC opinion, the Commission drafts a proposal for a delegated 

act amending Annexes IV or V.  

•  The procedure would be triggered on request of the Commission to ECHA; the request is expected 

to come as a follow up to the Stockholm Convention amendments.  

Task 2 

As part of the legislative proposal on data, the operation of the Information Platform for Chemical 
Monitoring is to be incorporated into the operation of the Common Data Platform on Chemicals and 
hosting of the collected monitoring data shall be done by the Agencies according to their mandates. 
This means that EEA will host all monitoring data in the environment.  

To reflect the change of the situation with hosting the data and operation of IPCHEM, there is a need 
to  change  the  process  in  POPs  regulation.  Therefore,  Member  States  can  make  the  relevant  data 
available  to  the  European  Envrionment  Agency  instead  of  the  IPCHEM  and  when  done  so,  the 
reproting obligatio under Article 13 (1)(e) shall be considered fulfilled. When ECHA receives such 
monitoring data, it shall provide it for hosting to EEA instead of IPCHEM.  

It shoud be noted that proposal for revision of water legislation requires Member States to share with 
EEA  all  monitoring  data  in  waters.  When  adopted  and  enforced,  EEA  would  have  practically  all 
monitoring data in the environment and thus the reporting under POPs would be fulfilled.  

Proximity to Agencies’ mandate: 

ECHA (Task 1):  Some aspects  could  be quite similar to  that performed  by ECHA under REACH 
restrictions (environmental and human health risk assessment + socio-economic analysis), although 
technical  waste-related  aspects  need  to  be  considered  more  (e.g.  recycling  targets  and  technical 
limitations).  

EEA (Task 2):  The task of hosting chemical monitoring data in the environment is a key part of the 
EEA mandate and thus the new task fits very well with its mandate. The existing tools and practices 
can be reused.  

Projected synergies and added value of the reattribution: 

Task 1 (ECHA): 

Type 

Synergies 

Reuse of 
capabilities 

High 

Process and expertise: ECHA already supports other work under the 
POPs Regulation and performs similar work on restrictions, setting 
of limit values and assessing socio-economic impacts under REACH 
and other legislation. Several key capacities can be 
reused/reinforced: 

124 

 
 
−  Hazard, risk, exposure and especially also socio-economic 

assessment 

−  Exposure limit value definition 
− 

IT capabilities for stakeholder consultation and dissemination 

Low 

Reuse of data collected under other chemical legislation, but low 
availability of data on substances in products and waste streams. 

Medium 

In a 5-year cycle, the workload of Agency experts and Committee 
experts can be balanced (although resource estimates are already 
annualised). 

Low 

Not an IT-intensive process, but reuse of IT capabilities for case 
management, public consultation, interaction with Member States, 
regulatory intentions management and data dissemination. 

High 

Reuse of scientific support services (e.g. , prioritisation and grouping 
of substances, substance identification, data management and 
dissemination). Reuse of administrative services. 

Re-use of 
data 

Workload 
balancing 

IT tools: 
automation 
and 
economies of 
scale 

Support 
services: 
economies of 
scale 

Type 

Added value 

Scientific 
consistency 

High 

Opportunity to align priority setting, timeline, process and 
methodology with other related legislation. Reuse of data collected 
under other chemical legislation. 

Robustness of 
assessment and 
acceptance 

High 

Insourcing of scientific work from consultants to Agency experts. 

(See also European Court of Auditors: External consultants at the 
European Commission - Scope for reform). 

Independence  High 

Moving scientific work from consultants to Agency experts . 
ECHA works under strict conflict of interest avoidance rules, 
improving guarantees of independent scientific advice to the 
Commission. 

Transparency  High 

ECHA works fully transparent: 

-  Overall process transparency 
-  Publication of regulatory intentions of EU authorities 
improves predictability for industry stakeholders 

-  Public consultation/call for evidence 
-  Stakeholder involvement/observer status 
-  Dissemination of scientific data and outcomes 

Task 2 (EEA): 

Type 

Synergies 

125 

 
 
 
Reuse of 
capabilities 

High 

Process and expertise: EEA already collects and host the chemical 
monitoring data in the environment. Several key capacities can be 
reused/reinforced: 

−  Collection and reporting tools 
−  Network of Member States experts on data in the 

environment 

High 

Reuse of data collected under water and air legislation 

High 

High 

The workload can be integrated in the existing processes and can be 
spread over time as necessary.  

The existing reporting tools and IT capabilities used for water and air 
legislation (Reportnet 3.0) can be fully reused after small adaptation.  

High 

Reuse of scientific support services and data dissemination. Reuse of 
administrative services. 

Re-use of 
data 

Workload 
balancing 

IT tools: 
automation 
and 
economies of 
scale 

Support 
services: 
economies of 
scale 

Type 

Added value 

Scientific 
consistency 

High 

Opportunity to align the formats and storing practices and thus 
ensure interoperability.  

Main risks and opportunities:  

Task 1: The risk assessment to be applied for the development of concentration limits is a mixture of 
hazard and socio-economic analysis with a strong focus on technical waste-related aspects, for which 
ECHA  does  not  have  a  ready  expertise.  Commission  and  other  stakeholders  would  benefit  from 
ECHA’s extensive knowledge on hazard and risk assessment as well as of socio-economic analysis; 
As production shifts from primary to secondary raw materials, it would be an opportunity for ECHA 
to better understand the related hazards and risks as substances/materials re-enter supply chains under 
REACH  jurisdictions  or,  when  this  is  not  possible,  are  disposed  of  in  an  environmentally  sound 
manner, as waste. 

Task 2: If and when the legislative proposal on revision of water legislation made in October 2022 
will be adopted, there is an opportunity to completely abandon the reporting of monitoring data under 
the POP regulation as the data will be reported under new provisions of water legislation. There is a 
clear opportunity from consolidating the chemical monitoring data in the environment and humans in 
EEA.  

Projected impact on Agencies: 

ECHA (Task 1): 

•  ECHA Committees/bodies: medium impact. The task generates medium impact on the 

setup / organisation / staffing of Committees/bodies due to the additional workload The task 
requires involvement of SEAC committee  

126 

 
 
 
RAC 

# of 
opinions 
per year 

0 

rapporteur  Type of 
opinion 

SEAC 

# of 
opinions 
per year 

rapporteur  Type of 
opinion 

2 

ECHA 

Setting waste 
limit values in 
Annex IV and 
V 

•  ECHA  data  model  and  IT  infrastructure:  low  impact.  The  task  can  be  implemented  with 

adjustments / configuration of existing data structures and IT systems 

•  ECHA key experts: high impact. The task heavily relies on expert competencies, which are 
limited within ECHA and also critical to REACH/CLP/BPR regulatory tasks. New expertise 
will need to be built to cover waste management.  

EEA (Task 2): 

•  EEA  Committees/bodies:  no  impact.    The  task  does  not  require  involvement  of  EEA 

Committees/bodies 

•  EEA  data  model  and  IT  infrastructure:  low  impact.  The  task  can  be  implemented  with 

adjustments / configuration of existing data structures and IT systems 

•  EEA  key  experts:  low  impact.  The  task  relies  on  the  expertise  that  already  exists  in  the 

agency.  

Workload and resource implications:  

Current workload and resource use: 

Currently, there are 25 limit values for individual substances or groups of substances. The workload 
driver  is  adding  substances  to  the  Stockholm  Convention  (new  POP  is  also  new  entry  here).  The 
experience shows that about 2 substances are added to Stockholm Convention every 2 years. Another 
workload driver are review clauses that are added to substances, usually to be reviewed after 5 years. 
This  depends on the initiative of the Commission. Changes in  exemptions  may also  influence the 
need for an Annex IV review (due to changes in Annex A or B of the Stockholm Convention), but 
not  so  often.  For  both,  reviews  and  changes  in  exemptions,  the  workload  is  lower  compared  to 
developing limit values for new substances as all the basic work has already been done. 

For the latest proposal to amend Annexes IV and V of the POP Regulation, COM (2021) 656 final, 
DG ENV used circa EUR 200 000 (but also relied on a preceding study of ca. EUR 100 000 covering 
hazard / risk aspects) for the support study for the impact assessment with proposals for limit values 
for 8 substances: 

-  3 new and recently listed substances to the Stockholm Convention 
-  1 substance that was under consideration by the POP Review Committee of the 
Convention as a candidate (and which was added to Annex I in June 2022) 

-  2 substances already listed in the Annex IV POP Regulation for review 
-  2 substances already listed in the Annex IV POP Regulation for adaptation to scientific 

and technical progress 

20 % of the budget for this support study was dedicated to the update of information on mass flows 
associated with the POP substances in question and their presence in waste (earlier reports already 
identified  these  mass  flows).  60  %  of  the  budget  for  this  support  study  was  dedicated  to  the  (i) 
compilation  of  information  in  support  of  the  IA,  (ii)  stakeholder  consultation  activities,  (iii) 
127 

 
 
 
 
 
 
 
 
 
 
 
comparative assessment of the impact for each concentration limit option and (iv) the proposal and 
justification of the low POP concentration limits for the 8 substances. One desk officer in DG ENV 
worked on this task 50% for 3 years, plus contractors 3 staff for 1 year. The final impact assessment 
was written by the DG ENV staff member. DG ENV staff involvement further includes process until 
adoption  by  the  College  (RSB  submission,  ISC,  etc)  and  involvement  in  the  co-decision  process 
(multiple interactions with the Working Party for the Environment of the Council, interaction with 
MEPs and MEP assistants in the ENVI Committee and participation in trilogues).   
The current resources spent by the Commission can be summarized as follows: 

DG ENV 

DG ENV consultants 

0.5 FTE per year 

4.5 FTEs (EUR 300 000 for consultants) every 
3 years (i.e. 1.5 FTE per year) 

Total 

Ca. 2.0 FTEs annually 

(to convert the cost of consultants into FTEs, the cost of 1 FTE consultant is estimated at ca. EUR 
66 000 annually) 

It should be noted that such Commission resources do not include contributions to the administrative 
overhead of the Commission (HR, Finance, IT tools, etc.).  

Current budget line: DG Environment  

Future workload and resource needs: 

Task 1 

It is expected that the number of substances added to the Stockholm Convention will continue to be 
about  2  substances  every  2  years,  or  1  substance  per  year  on  average.  Based  on  current  review 
commitments established in review clauses in the POPs Regulation, it is expected that about 5 reviews 
of existing limit values will be necessary every 5 year, i.e. on average 1 review per year. 

The Commission wishes to change the procedure for amendment of Annexes IV and V from ordinary 
legislative procedure to delegated act to reduce the administrative burden on the EU institutions and 
to make the procedure proportional to its impact.  

In order to have a scrutiny of socio-economic impacts of the chosen limit values robust and of high 
quality, the Commission wishes to get an opinion of the Committee for Socio-Economic Analysis on 
the proposed limit values, based on a prior ECHA report.   

The process would be to some extent similar to REACH restrictions with limit values or to the setting 
the Occupation Exposure Levels, with an average cost in ECHA of 1 (light dossier) – 1.5 (complex 
dossier) FTE / restriction dossier, but only with the scrutiny by SEAC and not by RAC. The detailed 
resource needs estimation for ECHA is as follows: 

•  On average there is a need to develop 1 new dossier every year + SEAC opinion forming: 1 
FTE/year, as there is no involvement of RAC (because most of the hazard assessment work 
has  been  done  already  at  the  Stockholm  Convention  level  and  the  unit  cost  of  1  REACH 
restriction are approximately 1 (light dossier) to 1.5 (complex dossier) FTEs) 

•  Review of existing 5 substance limit values every 5 years, or on average 1 substance every 

year (at 50% effort of full new dossier) = 0.5 FTE / year 

•  Scientific support services: substance identification and prioritisation, data management and 

dissemination: additional work to be absorbed by the Agency 
IT  tool  development  cost  (data  submission,  processing,  output):  contribution  of  15%  for 

• 

128 

 
 
 
 
common components (0.25 FTE per year) 

•  Horizontal support (governance & enablers / administrative overhead): contribution of 15% 

(0.25 FTE per year) 

----------- 

Total: 2 FTEs per year  

Task 2 

The  reporting  of  chemicals  monitoring  data  under  POPs  regulation  will  require  no  or  only  very 
minimal additional resources, as POPs monitoring data in waters are to be reported under the water 
legislation  and  resources  for  that  were  proposed,  POPs  monitoring  data  in  air  are  already  being 
reported to EEA as part of the air quality legislation and there are only very limited additional data 
sets in the environment, mainly in soil which is usually collected by JRC. In addition, hosting of any 
additional data sets in the environment is also covered in the resource for common data platform.  

Summary of additional resource needs for the POPs regulation: 

Agency 

ECHA 

Summary of tasks 

Financial resource needs: 

Human resource needs: 

EEA 

Financial resource needs: 

Human resource needs: 

2024: EUR 0  
2025: EUR 35 000 
2026: EUR 50 000 
2027: EUR 50 000 
2028: EUR 50 000 
2024: 0 TAs, 0 CAs 
2025: 1 TAs, 0 CAs 
2026: 2 TAs, 0 CAs 
2027: 2 TAs, 0 CAs 
2028: 2 TAs, 0 CAs 
2024: EUR 0  
2025: EUR 0 
2026: EUR 0 
2027: EUR 0 
2028: EUR 0 

2024: 0 TAs, 0 CAs 
2025: 0 TAs, 0 CAs 
2026: 0 TAs, 0 CAs 
2027: 0 TAs, 0 CAs 
2028: 0 TAs, 0 CAs 

Future budget line: DG Environment  

Candidate for fees: No 

16.  MEDICAL DEVICES REGULATION 

Responsible body: 

Currently: Commission with the support of the SCHEER Committee 

(Re-)attribution planned to: ECHA 

Legal basis for (re-)attribution: Omnibus regulation for reattribution of tasks 

Type of task: existing 

Brief task overview: (1) Preparation and review of the guidelines on how to perform the benefit-risk 
assessment  of  the  presence  of  phthalates  in  medical  devices;  (2)  Preparation  and  review  of  the 
guidelines on how to perform the benefit-risk assessment of the presence of CMR and endocrine-
disrupting substances in medical devices. (3) Ad hoc requests for opinion on safety of a chemical in 

129 

 
 
 
 
 
 
 
medical devices (not part of the proposal but possible based on general clause in ECHA founding 
regulation).  

Detailed process description: 

Current process: 

Article 5 paragraph 2 of the Regulation 2017/745 on medical devices stipulates: "A device shall meet 
the general safety and performance requirements set out in Annex I which apply to it, taking into 
account its intended purpose." Accordingly, Section 10.4 of Annex I, which deals with substances in 
medical devices, states that "Devices shall be designed and manufactured in such a way as to reduce 
as  far  as  possible  the  risks  posed  by  substances  or  particles,  including  wear  debris,  degradation 
products  and processing  residues, that may be released  from  the device."  Particular substances of 
concern are those which (a) are carcinogenic, mutagenic or toxic to reproduction (CMR), of category 
1A or 1B, or (b) have endocrine-disrupting properties (ED).  

The Regulation further states that:  

"Devices, or those parts thereof or those materials used therein that: 

•  are invasive and come into direct contact with the human body, 
• 

(re)administer medicines, body liquids or other substances, including gases, to/from the 
body, or 
transport or store such medicines, body fluids or substances, including gases, to be 
(re)administered to the body 

• 

shall  only  contain  any  such  substance  above  the  concentration  of  0.1%  weight  by  weight  where 
justified pursuant to Section 10.4.2. The justification shall be based on several elements, including 
the latest relevant scientific committee guidelines, if applicable and available.” 

Specifically for phtalates, according to Section 10.4.3, the Commission shall provide a mandate to 
the relevant scientific committee to prepare such guidelines for phthalates which are subject to these 
provisions. These guidelines are explicitly requested by the Regulation to be available at the latest on 
the date of application of the Regulation, and are to be updated whenever appropriate on the basis of 
the latest scientific evidence, or at least every five years. In its latest guidelines of 2019, the SCHEER 
recommended that “Pending on new scientific evidence, it is recommended to evaluate the use and 
usefulness of these Guidelines after an application period of three years.” 

The Regulation also includes the option for the Commission to mandate the relevant committee to 
prepare guidelines on other CMR and endocrine-disrupting substances, where appropriate. 

Upon request by DG SANTE, the guidelines and opinions are produced by the relevant committee 
(SCHEER). The process includes public consultation. Opinions are delivered to the Commission who 
publishes  them.  The  list  of  recent  SCHEER  opinions  is    https://health.ec.europa.eu/scientific-
committees/scientific-committee-health-environmental-and-emerging-risks-scheer/scheer-
opinions_en  

The first guideline on how to perform the benefit-risk assessment of the presence of phthalates in 
medical devices was prepared by SCHEER committee on request of the Commission in 2019. The 
guideline is available here and an example of benefit/risk assessment opinion on a substance (DEHP) 
is available here. 

There  was  no  request  for  the  preparation  of  the  guidelines  on  how  to  perform  the  benefit-risk 
assessment of the presence of CMR and endocrine-disrupting substances in medical device and no 
such guidelines exists.  

Changes in the process: Yes 

130 

 
 
The Commission would request ECHA to prepare or review the guidelines on how to perform the 
benefit-risk assessment of the presence of CMRs, endocrine disruptors and phthalates. The guideline 
would be developed or reviewed by ECHA secretariat and when appropriate or when requested by 
the  Commission,  ECHA  will  consult  the  Committee  for  Risk  Assessment  and  the  Committee  for 
Socio-Economic Analysis.  

The process would follow a standardised procedure, including most likely the following steps: 

-  The Commission issues the request for an opinion 
-  Substance identification and prioritisation 
-  Dossier preparation (by ECHA staff) with risk assessment, including 

o  Hazard/risk assessment 
o  Exposure assessment 
o  Assessment of alternatives 

-  Call for evidence/public consultation 
-  Potentially RAC opinion development 
-  Potentially SEAC opinion development  

Proximity to ECHA mandate: The development of the guidelines on how to perform the risk-benefit 
analysis  for  the  use  of  substances  fits  well  with  the  mandate  of  ECHA,  which  develops  various 
guidelines  for  industry  for  the  implementation  of  REACH  (e.g.  guidelines  on  risk  assessment  of 
chemicals,  guidelines  on  assessment  of  alternatives  of  chemicals,  guideline  on  socio-economic 
assessment).   

Projected synergies and added value of reattribution: 

Type 

Synergies 

Reuse of 
capabilities 

High 

Process and expertise: ECHA already provides scientific advice on 
chemical substances, including on phthalates, endocrine disruptors 
and CMRs under REACH and other legislation. Several key 
capacities can be reused/reinforced: 

-  Hazard, risk, exposure and socio-economic assessment 
-  Committee opinion development 
- 

IT capabilities for stakeholder consultation and 
dissemination (including regulatory intentions) 

Re-use of data  High 

Reuse of data collected under other chemical legislation, especially 
also on substances in products such as medical devices via the SCIP 
database. 

Workload 
balancing 

Medium 

In a 5-year cycle, the workload of Agency experts and Committee 
experts can be balanced (although resource estimates are already 
annualised). 

High 

High 

IT tools: 
automation 
and economies 
of scale 

Support 
services: 
economies of 
scale 

Not an IT-intensive process, but reuse of IT capabilities for case 
management, public consultation, interaction with Member States, 
regulatory intentions management and data dissemination. 

Reuse of scientific support services (e.g. committee secretariat, 
prioritisation and grouping of substances, substance identification, 
data management and dissemination). Reuse of administrative 
services. 

131 

 
 
Type 

Added value 

Scientific 
consistency 

High 

Opportunity to align priority setting, timeline, process and 
methodology with other related legislation to improve coherence in 
the scientific advice provided to the Commission. Reuse of data 
collected under other chemical legislation. 

Robustness of 
assessment and 
acceptance 

High 

Centralising scientific work from dispersed Commission services 
and committees to one central EU Agency and its experts. 
Involvement of ECHA’s scientific committees adds more scientific 
robustness to the process. 

Independence  High 

Moving scientific work from dispersed Commission services and 
committees to Agency experts and well-established committees in 
the European Chemicals Agency with a stricter separation between 
science and policy. ECHA and its committees work under stricter 
conflict of interest avoidance rules, improving guarantees of 
independent scientific advice to the Commission. 

Transparency  High 

ECHA’s involvement will bring additional transparency to the 
process: 

-  Overall process transparency 
-  Publication of regulatory intentions of EU authorities 
improves predictability for industry stakeholders 

-  Public consultation/call for evidence 
-  Stakeholder involvement/observer status 
-  Dissemination of scientific data and outcomes 

Projected impact on ECHA: 

•  ECHA  Committees/bodies:  low  impact.  The  task  generates  low  impact  on  the  setup  / 
organisation / staffing of Committees/bodies. The involvement of committees is on ad hoc 
basis, maximum one opinion every 5 years  

•  ECHA  data  model  and  IT  infrastructure:  low  impact.  The  task  can  be  implemented  with 

adjustments / configuration of existing data structures and IT systems 

•  ECHA  key  experts:  medium  impact.  The  task  relies  on  expert  competencies,  which  are 

limited within ECHA and also critical to REACH/CLP/BPR regulatory tasks 

Workload and resource implications: 

Current workload and resource use 

The SCHEER Committee has worked on six chemical-related medical device opinions in the period 
2014-2022 (i.e. average of 1 opinion every 2 years): 

Medical Devices  
Guidelines on the benefit-risk assessment of the presence of phthalates in certain 
medical devices covering phthalates which are carcinogenic, mutagenic, toxic to 
reproduction (CMR) or have endocrine-disrupting (ED) properties 
Opinion on the safety of medical devices containing DEHP-plasticized PVC or  Feb 2016 

June 2019 

132 

 
 
 
 
 
 
other plasticizers on neonates and other groups possibly at risk 
Opinion  on  the  safety  of  dental  amalgam  and  alternative  dental  restoration 
materials for patients and users 
Opinion on the safety of surgical meshes used in urogynaecological surgery 
Opinion on the safety of the use of bisphenol A in medical devices 
Opinion on the safety of Metal-on-Metal joint replacements with a particular focus 
on hip implants 

Apr 2015 

Dec 2015 
Feb 2015 
Sept 2014 

The DG SANTE Secretariat covers both SCCS and SCHEER tasks and consists of 4 FTE from the 
Commission staff + 2 FTE from an outsourced contract (EUR 250 000 annually) for technical and 
administrative support (literature search,  editing  and proofreading of opinions, website mastering, 
assistance for the Health-EU newsletter, dissemination activities), equally split over both committees.  
The SCHEER committee itself consists of 17 external experts. The advice on chemicals in medical 
devices can be roughly estimated to constitute ca. 10 % of the work of the SCHEER committee (4 
out  of  29  opinions  during  2015-2022),  which  corresponds  to  ca.  0.3  FTE  (10%  of  3  FTEs  from 
SCHEER secretariat). 

The operational costs for two committees (that includes special indemnities, accommodation, daily 
allowances, travel costs, reimbursement for rapporteurship, etc) operated by the Commission were 
EUR 2 883 030 for 6 years (2016-2021), which makes it approximately EUR 240 000 per year per 
committee. It must be noted that the operational costs in 2019 were EUR 340 000, which then went 
down because of the pandemic measures. The workload of SCHEER dedicated to support of medical 
devices regulation amounts to 10% of its time, which corresponds to operational costs of EUR 24 000 
(or at higher level of 2019 to EUR 34 000). 

The DG SANTE medical device unit spends, according to its own accounts, 0.1 FTE annually on 
following up on such scientific opinions requested from SCHEER.  

The current resources spent by the Commission can be summarized as follows: 

DG SANTE (policy unit) 

0.1 FTE per year 

DG SANTE (Committees unit, including 
external support) 

0.3 FTE (10% of the SCHEER secretariat) 
Operational costs ca. EUR 24 000/year (at peak 
EUR 34 000/year) 

Total 

Ca. 0.4 FTEs annually 

It should be noted that such Commission resources do not include contributions to the administrative 
overhead of the Commission (HR, Finance, IT tools, etc.).  

Current budget line: Budget line of DG SANTE (EU4Health programme) 

Future workload and resource needs: 

The  review  of  the  guidelines  on  how  to  performing  risk-benefit  analysis  of  use  of  phthalates  in 
medical devices is due in 2024. It will be still reviewed by the SCHEER committee, the work has 
started in April 2023. The next review will be due in 2029.  

The Commission does not envisage in the near future asking for the guidelines on how to perform 
risk-benefit analysis of use of CMRs and ED in medical devices.  

ECHA resource needs would be as follows: 

133 

 
 
 
 
•  Development  of  a  guideline  for  performing  risk-benefit  assessment  of  the  presence  of 
phthalates in certain medical devices every 5 years, including, where requested or appropriate, 
scientific committee opinion forming: 0.2 FTE (~unit cost of 1 REACH restriction = 1 (light 
dossier) – 1.5 (complex dossier) FTE) 

•  Development of a guideline for performing risk-benefit assessment on the use of CMR and 
endocrine-disrupting  substances  or  other  ad  hoc  mandate  on  chemicals  in  medical  devices 
every 5 years: 0.2 FTE (~unit cost of 1 REACH restriction = 1 – 1.5 FTE) 

•  Scientific support services: substance identification and prioritisation, data management and 

• 

dissemination: contribution of 0.1 FTE based on the size of the task 
IT tool development cost (data submission, processing, output): contribution of 15% for 
common components (0.1 FTE) 

•  Horizontal support (governance & enablers / administrative overhead): contribution of 15% 

(0.1 FTE) 

----------- 

Total: 0.7 FTEs 

Considering that the envisaged frequency of the work is very low, the involvement of the Committees 
is only where necessary, the first work will likely materialise only in 2029, the work can be absorbed 
by the agency without any additional resources.  

Summary of additional resource needs for the medical devices regulation: 

Agency 

ECHA 

Summary of tasks 

- Guideline on phthalates 

Financial resource needs: 

- Guideline on CMRs or EDs 

Human resource needs: 

2024: EUR 0  
2025: EUR 0 
2026: EUR 0 
2027: EUR 0 
2028: EUR 0 
2024:  0 FTE 
2025:  0 FTE 
2026:  0 FTE 
2027:  0 FTE 
2028:  0 FTE 

Future budget line: DG SANTE  

Candidate for fees: No 

17.  EEA FOUNDING REGULATION (1210/90) 

Responsible body: 

Currently: EEA 

(Re-)attribution planned to: EEA, expanding the existing tasks 

Legal basis for reattribution: omnibus regulation on reattribution of task 

Type of task: New 

Brief task overview:  

1.  Developing methodologies for assessment related to chemicals in the fields falling within its 

mission 

2.  Cooperating with other agencies as regards exchange of data, defining formats and controlled 

vocabularies and development of methodologies related to chemicals.  

Detailed process description: 

134 

 
 
 
 
 
Current process: 

Task 1 

EEA  has  some  very  specific  tasks  with  some  relevance  to  the  development  of  methodologies 
mentioned in the current founding regulation. These are:  

(iv) to help ensure that environmental data at European level are comparable and, if necessary, to 
encourage by appropriate means improved harmonization of methods of measurement;  

(viii) to stimulate the development of methods of assessing the cost of damage to the environment 
and the costs of environmental preventive, protection and restoration policies;  

(xii) to support the Commission in the process of exchange of information on the development of 
Environmental Assessment methodologies and best practice; 

EEA however lacks  the mandate and obligation to develop  methodologies and for the assessment 
related to chemicals. This disadvantages the EEA as compared to other agencies. 

Task 2 

The EEA founding regulation contains some provisions related cooperation. The Article 15 states:  

1. The Agency shall actively seek the cooperation of other Community bodies and programmes, and 
notably the Joint Research Centre, the Statistical Office and the Community's environmental research 
and development programmes. In particular:  

−  cooperation with the Joint Research Centre shall include the tasks set out in the Annex under 

A,  

−  coordination  with  the  Statistical  Office  of  the  European  Communities  (Eurostat)  and  the 
statistical programme of the European Communities will follow the guidelines outlined in the 
Annex under B. 

2. The Agency shall also cooperate actively with other bodies such as the European Space Agency, 
the  Organization  for  Economic  Cooperation  and  Development,  the  Council  of  Europe  and  the 
International Energy Agency as well as the United Nations and its specialized agencies, particularly 
the United Nations Environment Programme (UNEP), the World Meteorological Organization and 
the International Atomic Energy Authority. 

2a. The Agency may cooperate in areas of common interest with those institutions in countries 
which are not members of the European Communities which can provide data, information and 
expertise, methodologies of data collection, analysis and assessment which are of mutual interest 
and which are necessary for the successful completion of the Agency's work.  

3. The cooperation referred to in paragraphs 1, 2 and 2a must in particular take account of the need 
to avoid any duplication of effort. 

The Annex A to the regulation lists some areas for cooperation with JRC:  

A. Cooperation with the Joint Research Centre  

Intercalibration of instruments (1).  

−  Harmonization of environmental measurement methods (1).  
− 
−  Standardization of data formats.  
−  Development of new environmental measurement methods and instruments.  
−  Other tasks as agreed between the Executive Director of the Agency and the Director-

General of the Joint Research Centre. 

135 

 
 
The  existing  provisions  do  not  give  an  explicit  mandate  nor  obligation  to  EEA  to  cooperate  with 
ECHA,  EMA  and  EFSA  in  those  areas.  In  order  to  achieve  the  one  substance,  one  assessment 
ambition, it is necessary to strengthen the provisions on cooperation. 

Future process: 

Task 1: 

EEA  will  have  a  mandate  to  develop  methodologies  for  the  assessments  related  to  chemicals  it 
performs and it will develop such methodologies based on its needs. 

Task 2: 

EEA actively cooperates with ECHA, EFSA and EMA as regards: 

exchange of data on chemicals and defining formats and controlled vocabularies for such data 

- 
-  development of methodologies related to chemicals,  
-  operation of early warning system for chemicals  
-  operation of framework of indicators of chemical policies 

The  cooperation  is  foreseen  both  ways,  i.e.  when  EEA  itself  makes  some  development  in  those 
specified areas within its domain as well as when EFSA, ECHA and EMA make some development 
in those areas within their domains. The goal is to ensure coherence, consistency and interoperability 
in the specified areas.  

Proximity to Agency mandate: Both tasks fit well with the mandate of EEA as both tasks target the 
areas of the EEA mandate. 

Projected  synergies  and  added  value  of  reattribution:  Improving  coherence,  consistency  and 
interoperability among the Agencies work is the key added value.  

Projected impact on EEA: 

•  EEA Committees/bodies: no impact. The task does not involve the committee/network.  

•  EEA  data  model  and  IT  infrastructure:  low  impact.  The  task  can  be  implemented  with 

adjustments / configuration of existing data structures and IT systems 

•  EEA key experts: low impact. The task relies on expert competencies, but the task is limited 

and spread over time in its nature.  

Workload and resource implications: 

Future workload and resource needs: 

The work on the new tasks is limited and spread over time in it is nature. On a need basis, it requires 
that  EEA  will  develop  methodologies  for  the  assessment  it  performs  as  regards  chemicals.  The 
development  and  setting  the  methodology  is  a  standard  practice  for  whoever  performs  the 
assessments, so this task can be seen as a formalisation of existing EEA work. There is no need for 
additional resources for this task. 

EEA  will  also  need  to  cooperate  with  ECHA,  EFSA  and  EMA  in  the  areas  on  data,  formats, 
methodologies, early warning system and indicator framework. The need for additional resources for 
cooperation on these are already covered under the legislative proposal on data (operation of common 
data platform, operation of early warning system and operation of indicator framework) and there is 
no need for additional resources on this general formal mandate for agency to cooperate.  

Summary of additional resource needs for EEA founding regulation: 

Agency 

Summary of tasks 

EEA 

- Development of 
methodologies for 

Financial resource needs: 

2024: EUR 0  
2025: EUR 0 
2026: EUR 0 

136 

 
 
 
 
assessments related to 
chemicals within its 
missions  
- Cooperation with ECHA, 
EFSA, EMA on issues 
related to chemical 

Human resource needs: 

2027: EUR 0 
2028: EUR 0 
2024:  0 FTE 
2025:  0 FTE 
2026:  0 FTE 
2027:  0 FTE 
2028:  0 FTE 

Future budget line: DG Environment 

Candidate for fees: No 

18.  GENERAL FOOD LAW (178/2002) 

Responsible body: 

Currently: EFSA 

(Re-)attribution planned to: EFSA, expanding and modifying the existing tasks 

Legal basis for reattribution: omnibus regulation on reattribution of task 

Type of task: New 

Brief task overview:  

1.  Developing methodologies for assessment of chemicals in the fields falling within its mission 

2.  Cooperating with other agencies as regards exchange of data, defining formats and controlled 

vocabularies, development of methodologies related to chemicals 

3.  Preventing and solving divergent opinions on chemicals with ECHA and EMA 

Detailed process description: 

Current process: 

Task 1 

EFSA has a very clear tasks in Article 23 to promote and coordinate the development of uniform risk 
assessment methodologies in the fields falling within its mission. The mandate is sufficient and no 
change is required.  

Task 2 

The EFSA founding regulation contains some provisions related to cooperation. The Article 22 that 
defines the mission of EFSA states:  

7.  The Authority shall carry out  its tasks in  conditions which enable it to  serve as  a point of 
reference by virtue of its independence, the scientific and technical quality of the opinions it 
issues and the information it disseminates, the transparency of its procedures and methods of 
operation, 
It shall act in close cooperation with the competent bodies in the Member States that carry out 
similar  tasks  to  those  of  the  Authority  and,  where  appropriate,  with  the  relevant  Union 
agencies. 

performing 

diligence 

assigned 

tasks 

and 

the 

its 

in 

to 

it.   

The  existing  provisions  are  rather  general.  In  order  to  achieve  the  one  substance,  one  assessment 
ambition, it is necessary to strengthen the provisions on cooperation. 

Task 3 

EFSA  founding  regulation  specifies  provisions  for  preventing  and  solving  divergent  scientific 
opinions with other agencies. Article 30 states: 

137 

 
 
 
1.  The Authority shall exercise vigilance in order to identify at an early stage any potential source 
of divergence between its scientific opinions and the scientific opinions issued by other bodies 
carrying out similar tasks. 

2.  Where the Authority identifies a potential source of divergence, it shall contact the body in 
question to ensure that all relevant scientific information is shared and in order to identify 
potentially contentious scientific issues.  

3.  Where  a  substantive  divergence  over  scientific  issues  has  been  identified  and  the  body  in 
question  is  a  Community  agency  or  one  of  the  Commission's  Scientific  Committees,  the 
Authority and the body concerned shall be obliged to cooperate with a view to either resolving 
the divergence or presenting a joint document to the Commission clarifying the contentious 
scientific issues and identifying the relevant uncertainties in the data. This document shall be 
made public.  

4.  Where  a  substantive  divergence  over  scientific  issues  has  been  identified  and  the  body  in 
question  is  a  Member  State  body,  the  Authority  and  the  national  body  shall  be  obliged  to 
cooperate  with  a  view  to  either  resolving  the  divergence  or  preparing  a  joint  document 
clarifying  the  contentious  scientific  issues  and  identifying  the  relevant  uncertainties  in  the 
data. This document shall be made public. 

The  provisions  need  to  be  aligned  with  those  for  other  agencies.  In  addition,  there  is  a  need  to 
strengthen the requirement to solve the divergent view by agencies among themselves, before the 
matter is referred to the Commission to be solved.  

Future process: 

Task 1: 

The existing mandate for development of methodologies is sufficient and no change is required.  

Task 2: 

EFSA actively cooperates with ECHA, EEA and EMA as regards: 

exchange of data on chemicals and defining formats and controlled vocabularies for such data 

- 
-  development of methodologies related to chemicals,  
-  operation of early warning system for chemicals  
-  operation of framework of indicators of chemical policies 

The  cooperation  is  foreseen  both  ways,  i.e.  when  EFSA  itself  makes  some  development  in  those 
specified areas within its domain as well as when EEA, ECHA or EMA make some development in 
those areas within their domains. The goal is to ensure coherence, consistency and interoperability in 
the specified areas.  

Task 3: 

EFSA and body concerned shall first attempt to solve the divergent opinion on scientific or technical 
issues by themselves. They shall revert the decision to the Commission only if they were not able to 
solve  the  issue.  In  addition,  if  the  divergence  come  from  different  hazard  identification  or 
characterisation,  then  the  Commission  shall  request  ECHA  to  prepare  a  proposal  for  harmonised 
classification under the CLP regulation.  

Proximity to Agency mandate: The tasks fit well with the mandate of EFSA as both tasks target the 
areas of the EFSA mandate, and they are just improvement of existing tasks. 

Projected  synergies  and  added  value  of  reattribution:  Improving  coherence,  consistency  and 
interoperability among the Agencies work is the key added value.  

Projected impact on EFSA: 

•  EFSA Committees/bodies: low impact. The task might require some ad hoc involvement of 

committee/panels or their consultation.  

138 

 
 
•  EFSA  data  model  and  IT  infrastructure:  low  impact.  The  task  can  be  implemented  with 

adjustments / configuration of existing data structures and IT systems 

•  EFSA key experts: low impact. The task relies on expert competencies, but the task is limited 

and spread over time in its nature.  

Workload and resource implications: 

Future workload and resource needs: 

EFSA  will  need  to  cooperate  with  ECHA,  EEA  and  EMA  in  the  areas  on  data,  formats, 
methodologies, early warning system and indicator framework. The need for additional resources for 
cooperation on these are already covered under the legislative proposal on data (operation of common 
data platform) or they are already within the mandate of EFSA (early warning system). Consequently, 
there is no need for additional resources on this general formal mandate for Authority to cooperate. 

EFSA will need to try to solve any divergence in technical or scientific issue with the other agency. 
EFSA  already  has  such  obligation  in  the  existing  regulation.  The  new  task  will  require  that  the 
agencies  make  more  effort  to  solve  the  issue  among  themselves,  instead  of  just  forwarding  the 
problem  to  the  Commission.  Although  it  might  require  slightly  higher  amount  of  work  by  the 
Authority as compared to today, such situations are rare and therefore this can be absorbed by the 
Authority without any additional resources.  

Summary of additional resource needs for General Food Law regulation: 

Agency 

EFSA 

Summary of tasks 

- Cooperation with ECHA, EFSA, EMA on issues 
related to chemical 
- Preventing and solving divergent opinions or 
assessments  

Financial resource 
needs: 

Human resource 
needs: 

2024: EUR 0  
2025: EUR 0 
2026: EUR 0 
2027: EUR 0 
2028: EUR 0 
2024:  0 FTE 
2025:  0 FTE 
2026:  0 FTE 
2027:  0 FTE 
2028:  0 FTE 

Future budget line: None 

Candidate for fees: No 

19.  EU COMMON DATA PLATFORM ON CHEMICALS 

Responsible body: 

Currently: N/A, no current process 

(Re-)attribution planned to: ECHA, EFSA, EMA, EEA, EU-OSHA, JRCLegal basis for reattribution:  
Proposal for a regulation of the European Parliament and of the Council establishing a common data 
platform  on  chemicals,  laying  down  rules  to  ensure  that  the  data  contained  in  it  are  findable, 
accessible,  interoperable  and  reusable  and  establishing  a  monitoring  and  outlook  framework  for 
chemicals 

Type of task: new (new infrastructure but building on existing data and services) 

Brief task overview: Setting up and operation of the common data platform on chemicals.  

Detailed process description: 

139 

 
 
 
 
 
The principal aim of this new IT infrastructure operating as part of the Green Deal Data Space is to 
support  effective  and  coherent  chemical  safety  assessments.  It  will  provide  integrated,  user-
differentiated and highly functional access to chemicals-related datasets owned or managed by EU 
agencies and IPCHEM (see section 18 below) and provide space for dedicated services supporting 
EU chemicals policy and legislative implementation. Those dedicated services include the provision 
of  information  on  the  obligations  under  EU  acts  on  chemicals  (see  section  23),  a  repository  of 
reference values (see section 22), information on regulatory processes on chemicals (see section 21), 
information platform for chemical monitoring (see section 20) and the database on environmental 
sustainability related information on chemicals (see section 24). An integral aspect of the platform is 
its  governance,  ensuring  continuous  evolution  and  relevance  through  the  inclusion  of  further 
functionalities, datasets and services (e.g. on academic studies) and ensuring support to the thriving 
ecosystem of services outside the platform.  

Current process: 

A comprehensive assessment of the status of the chemicals data landscape was made in a feasibility 
study on a common open data platform58. There is a large amount of chemicals data in databases, 
much  of  it  compiled  following  legal  provisions  and  used  in  the  regulatory  processes  but  also 
disseminated by EU agencies and the Commission for transparency and public use. Comprehensive 
IT development has been taking place in the agencies, optimising tools applied to internal data within 
the sectors, at least in specific circumstances also using common building blocks (e.g. IUCLID for 
information  on  chemical  hazards).  IPCHEM  (see  section  20)  has  been  developed  for  use  across 
sectors but is limited to chemical occurrence data.  

Effective common access to different types of chemicals data across those solutions has however not 
been made available and is therefore also not systematically applied in EU chemicals assessments, 
also as any ad hoc integration is hampered by different conditions of use, differences in data formats 
and applied controlled vocabularies, not least for chemical substance identification.  

There  is  inefficiency  and  duplication  as  individual  projects  repeat  the  same  efforts  merging  and 
curating certain data across sectors for specific needs such as the validation of predictive tools. There 
is also a loss of coherence or there is even divergence between assessments of the same or similar 
substances or groups of substances due to differences in the datasets used.  

Changes envisioned as part of setting up the common data platform 

The feasibility study on a common open data platform on chemical safety data has already identified 
the steps needed to establish the platform and based on the input by various stakeholders identified a 
set  of  use  cases  that  could  be  prioritised  for  the  initial  implementation  of  the  platform,  with  the 
functionalities and datasets to be integrated. The work in the study has been validated by the experts 
responsible for the datasets considered for initial integration in the platform: a dedicated interservice 
team led by ECHA, identified as the appropriate host for the platform.  

The  team  turned  it  into  a  practical  3-year  development  and  operations  roadmap,  and  quantified 
resources in the Project Initiation Document. It can be summarised around three main headlines: 

•  design  and  construction  of  a  data  container:  the  technical  platform  solution  and  the  data 
definitions  and  ingestion  mechanisms  that  enable  it  to  receive  data.  While  ECHA  is 
responsible for the IT infrastructure of the data container, cooperation (and – depending on 
the data type – lead) by the other agencies in setting the data definitions and supporting the 
general  governance  of  the  platform  on  aspects  such  as  the  determination  of  basic 
functionalities (ingestion, use and outputs, dedicated services featuring in the platform) and 

58 Feasibility study on a common open platform on chemical safety data - Publications Office of the EU (europa.eu) 

140 

 
 
 
further evolution is essential.  

•  The  data  content  activities:  data  transformation,  curation  and  confidentiality  assessment. 
Upload  of  every  integrated  dataset  will,  while  based  on  commonly  agreed  rules  and 
vocabularies, and supported as appropriate with ingestion tools, remain the responsibility of 
the  data  source  owners  (i.e.  agencies),  unless  explicitly  agreed  otherwise.  For  data  source 
owners, this work will overlap with work on standard data formats and controlled vocabularies 
of own datasets. Preparation of dedicated services available in the platform will include both 
work  on  technical  platform  functionality  as  well  as  on  data  content.  Currently,  identified 
services (covered separately in the sections below) include: platform on chemicals monitoring 
(transfer  of  current  IPCHEM),  repository  of  reference  values,  information  on  obligations 
under  EU  acts  on  chemicals  (expansion  of  current  EUCLEF),  information  on  regulatory 
processes (expansion of current PACT),  repository of standard data formats and controlled 
vocabularies and database on environmental sustainability related data.  

The  comprehensive  roadmap  of  the  Project  Initiation  Document  includes  a  detailed  list  of  32 
deliverables on content (in addition to 8 deliverables related to project management), planned across 
the  three  years  of  development.  Herein  some  highlight  on  the  extent  of  planned  minimum  viable 
product (MVP): 

• 

Improving  the  quality  of  assessments  and  facilitating  a  one  substance-one  assessment 
approach  is  the  principal  supported  use  case;  other  use  cases  include  the  improvement  of 
quality of safety information and data, grouping and prioritisation of chemicals, enhancing 
knowledge  building  through  sharing  of  research  outcomes  (solution  under  development), 
provision of methods and standards. 

•  The  container/content  approach  to  the  development  of  the  technical  platform  will  be 
automated  to  the  extent  possible,  using  existing  ‘building  blocks’  i.e.  relevant  services 
provided by the cloud platform. It will follow the “intentional architecture, emergent designs” 
principle, leading to a container with availability of all necessary networking and development 
services in the public cloud, with the necessary management tools, identity rules, enforceable 
policies and security controls, and a modular and extensible character for further evolution of 
e.g. analytical functionalities.  

•  Each dataset planned for integration will be prepared for ingestion into the platform by: 
o  Basic curation / profiling / metadata according to platform requirements 
o  Mapping and conversion to agreed formats, use of controlled vocabularies 
o  Incorporation of agreed substance identifiers, controlled vocabularies and tagging 
o  Allocation of confidentiality levels / user groups (in MVP, confidential data should 

be filtered before being disseminated through the platform) 

o  Quality control after conversion 
o  Mechanisms for (periodic) ingestion by the platform; updates, versioning 

•  The following datasets will be included in the MVP integration: 

o  ECHA  REACH:  REACH  registrations  including  Chemical  Safety  Reports  (CSR). 
This dataset already features IUCLID formatted data covering substance information, 
physico-chemical  properties,  (eco)toxicological  data,  environmental  fate  and  use 
information for more than 24 000 unique substances. 

o  ECHA Classification, Labelling and Packaging (CLP): Classification and labelling 
(C&L)  inventory.  Based  on  industry  C&L  notifications  for  more  than  200 000 
substances  and  EU  harmonised  classifications  for  ca.  4  600  substances.  The  C&L 
inventory is based on a IUCLID C&L format and structured metadata. 

o  ECHA  Biocidal  Products  Regulation  (BPR):  biocidal  active  substance  approval 
process data features more than 900 active substance-product type combinations. The 

141 

 
 
authorised  biocidal  products  dataset  contains  over  6  000  approved  products.  The 
process information is in a structured format but assessment reports, opinions etc. are 
included as attachments. The conversion of SPCs (summary of product characteristics) 
IUCLID format is underway. 

o  ECHA Prior Informed Consent (PIC): Substances subject to PIC the Regulation (ca 

260 listed substances or substance groups). 

o  ECHA  Persistent  Organic  Pollutants  (POP):  1)  list  of  POPs,  featuring  30 
substances or substance groups; 2) list of substances proposed to be included in the 
POP list of the Stockholm Convention.  

o  EFSA  OpenFoodTox:  summary  of  all  EFSA  chemical  risk  assessments  including 
chemical  identifiers, critical  endpoints, toxicological  reference values and metadata 
from EFSA outputs. 

o  EFSA  Chemical  Monitoring  Data:    Chemical  monitoring  data  for  pesticides  and 
veterinary  medicinal  product  residues  and  contaminants  data.  The  individual 
measurements of chemicals in food/feed and other materials sampled as part of official 
controls  and enforcement  activities in  SSD2 format. Sampling  by member states  is 
legally mandated under Regulation (EU) 2017/625 and associated implementing acts. 
Additionally, measurements of chemicals in food and feed received from industry or 
other sources in response to call for data. This data is available in IPCHEM. 

o  EFSA OpenEFSA: All information related to EFSA's scientific work. Tracking of the 
risk assessment process from receipt of dossier to adoption of the opinion. Information 
available includes status of assessments, dossiers and studies, meeting agendas and 
minutes, information on experts (DOIs), public consultations). 

o  EFSA  EU_PPP  Agency  IUCLID:  IUCLID  dossiers  submitted  by  applicants 
(industry)  under  Regulation  (EC)  No  1107/2009  concerning  the  placing  of  plant 
protection  products  on  the  market.  Four  submission  types  are  supported,  EU  PPP 
Active substance, EU PPP Microorganism, EU PPP Maximum Residues Levels, EU 
PPP Basic substance. 

o  EEA Air Quality: The EEA gathers air quality  data from  a wide range  of sources 
including  current  status  of Europe’s  air quality  through five different  air pollutants 
(European  Air  Quality  Index),  latest  measurements  from  Europe's  air  quality 
monitoring network and Statistics for air pollutants calculated from officially-verified 
country data for years until ‘X-2’. 

o  EEA Waterbase Water Quality: The dataset contains time series of concentrations 
of nutrients, organic matter, hazardous substances and other chemicals in rivers, lakes, 
groundwater, transitional, coastal and marine waters. This database also contains the 
records reported under the Water Framework Directive Watch List for chemicals in 
surface waters. 

o  EEA Waterbase emissions: The dataset contains time series of emissions of nutrients 
and  hazardous  substances  to  water,  reported  by  EEA  member  countries  and 
cooperating  countries.  It  also  contains  data  on  yearly  riverine  input  loads  to 
transitional, coastal and marine waters. 

o  EEA Industrial emissions: The data set contains data reported by Member States in 
the scope of the E-PRTR Regulation and Industrial Emissions Directive. The data is 
reported annually and includes releases to air/water/land and pollutant transfers of 91 
pollutants and waste transfers of hazardous and non-hazardous waste (facilities in the 
scope of E-PRTR);  environmental permit  information, application of best  available 
techniques (BAT) conclusions, inspections and other information on IED installations; 
air  emissions,  operating  hours  and  energy  input  from  large  combustion  plants;  and 
nominal  capacity  from  waste  incinerators.  This  data  is  contained  within  the  same 

142 

 
 
database. The information is  displayed in  the European  Industrial  Emissions  Portal 
and the full database is published on the EEA data service in access format, with some 
extracts published as Excel spreadsheets. 

o  EEA  National  Emission  reductions  Commitments  (NEC)  Directive  emission 
inventory data:  Data on emissions of air pollutants (ammonia (NH3), non-methane 
volatile organic compounds (NMVOC), nitrogen oxides (NOx), particulate matter 2.5 
(PM2.5)  and  sulphur  dioxide  (SO2))  reported  annually  by  Member  States  to  the 
European  Commission  (with  copies  to  EEA)  under  Directive  2016/2284  of  the 
European  Parliament  and  of  the  Council  on  the  reduction  of  national  emissions  of 
certain atmospheric pollutants. 

o  EMA  human  medicinal  products  data  (environmental  risk  assessment  and  non-

clinical safety data) 

o  EMA veterinary medicinal products (environmental risk assessment and maximum 

residue limit (MRL) values and MRL assessment data) 

•  IPCHEM (JRC): the existing platform for chemical occurrence data in its function and with 
data will be integrated into the common data platform in two steps (see also section 18). Its 
data is structured into four modules, according to the chemical monitoring data categorisation: 
Environmental monitoring, Human Bio-Monitoring, Food and Feed, and Products and Indoor 
Air.  

•  Further datasets to be integrated are identified also as dedicated services as they include the 

need for preparation and curation: 

o  Regulatory  processes  information:  9  different  ECHA  processes  and  related 
regulatory process data are currently included ECHA’s Public Activities Coordination 
Tool (PACT), providing an overview of substance-specific activities. The scope of the 
tool under the platform (see section 19) will include contributions by all the agencies.  
o  EU  Chemicals  Legislation  Finder  (EUCLEF):  An  overview  of  the  European 
Union’s  legislation  on  chemicals.  This  existing  service  by  ECHA  will  in  future  be 
included  under  the  platform  (see  section  23).  It  currently  contains  51  pieces  of 
legislation  and  is  integrated  in  ECHA’s  substance  database.  For  each  piece  of 
legislation  included  in  EUCLEF,  a  summary  is  provided  containing  the  scope, 
obligations,  exemptions,  regulatory  activities  and  lists  of  impacted  substances, 
together with links to the full legal texts in all EU languages. The data management of 
EUCLEF data is outsourced by ECHA to a service provider.  

o  Repository of reference values: reference values covered by the datasets described 
above  will  be  made  available  from  the  moment  the  datasets  are  ingested  in  the 
platform. The outcome of the related Health-based limit value repository (HBLVR) 
study  will  inform  when  and  in  which  format  the  additional  datasets  could  be 
incorporated in the platform. 

o  Formats and controlled vocabularies: agreed rules will be effectively shared on the 
platform  itself  for  integration  purposes  but  also  for  use  beyond  the  platform.  This 
dataset will include the work of (common) substance identification that can be then 
used across any substance-specific chemical datasets. 
. 

o 

• 

Introducing  principal  data-related  dimension  of  the  current  European  Observatory  for 
Nanomaterials (EUON) in the common data platform has been agreed through identification 
of the observatory as one of further dedicated services on the platform, allowing it also to 
expand to other chemicals/materials selected to benefit from such additional compilation.  

•  As part of the new study notification mechanism, a database of study notifications will be 

established and accessible through the common data platform.  

143 

 
 
Proximity to the mandate of the EU agencies: While ECHA’s core mandate is focused on the safety 
assessment  of  chemicals,  it  also  includes  the  dissemination  of  information  on  chemicals  and,  as 
expressed in its vision, being ‘the centre of knowledge on the sustainable management of chemicals’. 
A  better  sharing  of  data  between  EU  authorities  can  contribute  to  the  success  of  ECHA’s  core 
mandate.  There  is  a  similar  proximity  in  the  mandates  of  the  other  agencies  involved  in  the 
development  and  operation  of  the  platform  through  collaboration  on  the  interoperability  of  their 
respective data to be integrated in the platform. The use of shared data can contribute to the success 
of their core mandates when tasked with assessments involving chemicals.  

Projected synergies and added value of (re)attribution: 

Type 

Synergies 

Reuse of 
capabilities 

High 

Process and expertise: ECHA and other agencies already support 
similar work on data dissemination under REACH and other 
legislation. Several key capacities can be reused/reinforced: 

- 

- 

IT capabilities for data integration and public and 
confidential data dissemination  
IT capabilities for data submission and publication of 
regulatory intentions 

-  solutions of the chemicals legislation finder and chemical 

occurrence data IPCHEM 

Re-use of data  High 

Reuse of data collected under other chemical legislation to populate 
the new platform aimed to facilitate re-use by ECHA and other 
agencies (as well as other users). 

Workload 
balancing 

Low 

With IT development work clearly defined in a 3-year project plan 
and after that a running phase with much less resources, there is a 
clear resource plan and little or no room for workload balancing 
(and resource estimates are already annualised). 

High 

High 

IT tools: 
automation 
and economies 
of scale 

Support 
services: 
economies of 
scale 

Reuse of IT capabilities for regulatory intentions management and 
data dissemination building blocks. ECHA is also required to build 
an EU repository of reference values and manage the chemicals 
legislation finder, building on existing tools. 

Reuse of scientific support services (e.g. substance identification, 
data management and dissemination). Reuse of administrative 
services. 

Type 

Added value 

Scientific 
consistency 

High 

Opportunity to improve data sharing between EU authorities to 
improve coherence in the scientific advice provided to the 
Commission. Reuse of data collected under several chemical 
legislations. 

Robustness of 
assessment and 
acceptance 

High 

Centralising all data on chemicals in one central EU platform will 
broaden the knowledge base and improve the robustness of the 
scientific advice provided to the Commission; re-use of (same) data 

144 

 
 
 
will facilitate acceptance of conclusions. 

Independence 

Low 

/ 

Transparency  High 

Centralising all data on chemicals in one central EU platform will 
help to improve: 

-  Overall process transparency for EU chemicals legislation 
-  Predictability for industry stakeholders thanks to the 

publication of regulatory intentions  

-  Dissemination of scientific data and outcomes 

Main risks and opportunities:  

-  Risks: Complex IT project with many stakeholders. Needs robust governance, clear roles and 
responsibilities, resources and funding. Legal text needs to include legal basis for ECHA to 
build  and  host  and  govern  the  platform  and  for  other  EU  authorities  a  legal  obligation  to 
provide data.  

-  Opportunities:  The  proposal  for  a  regulation  establishing  a  common  data  platform  and  a 
monitoring  and  outlook  framework  for  chemicals  should  take  away  barriers  to  sharing 
(confidential) data and support its re-use. Opportunities include also further benefits arising 
from coordinated development of IT services between agencies and a frame that will facilitate 
the  evolution  of  existing  and  the  development  of  new  digital  services  and  application  of 
artificial intelligence based on chemicals data (e.g. predictive tools, safe and sustainable by 
design).  

Projected impact on agencies: 

•  Committees/bodies of the agencies: no impact. The task does not require the involvement of 

committees /bodies 

•  Data model(s) and IT infrastructure: high impact. The task requires investment in entirely 
new data structures and IT systems/capabilities, principally on ECHA’s side but also on the 
side of data source owners preparing datasets for integration into the common data platform 

•  Key experts: high impact. The task relies heavily on expert competencies; while an 

important segment of preparing the IT solutions can be outsourced, work on internal data 
linkages and rules supporting integration will rely on internal experts, which are limited 
within the agencies and also critical to ensure continuity of ongoing regulatory tasks 

Projected workload and resource implications:  

There are extensive resources already employed in current IT/data infrastructures of the agencies, and 
in the planning of the (re)attribution of tasks an IT overhead is considered to ensure the tasks are 
adequately  supported.  It  is  expected  that  some  reattribution  will  take  place  to  optimally  exploit 
synergies with the work on the common data platform. That platform is however a new infrastructure 
that in spite of longer-term benefits such as an increased effectiveness of tasks and efficiencies of 
individual IT solutions (formats, vocabularies, reusable building blocks, addressing at least part of 
dissemination  expectation  etc.)  requires  investment  to  be  developed,  to  prepare  the  datasets  in 
adequate formats and to cover necessary overhead for operations. For dedicated services described 
separately  in  specific  sections  below,  only  a  summary  of  the  resource  estimation  is  given  as  a 
repetition, in order to avoid potential double counting.  

145 

 
 
 
Estimates for agencies are made on the basis of the datasets identified to be included in the MVP (see 
above) and the current state of the dataset and under the assumption that ECHA develops and hosts 
the common data platform.  

The  estimation  of  workload/resources  required  is  targeting  different  aspects  of  the  platform’s 
lifecycle: 

Work description     

Who    Resource needs estimate  

Development of the platform  (including 
infrastructure costs until go-live) 

Project management 

Infrastructure setup 

Governance setup and operation 

Coordination of and consultation on 
common data formats, rules and 
controlled vocabularies, functionalities 
and platform evolution (future planning) 

Development by 2027; development duration 3 years for years 
2025, 2026, 2027, annual estimates of staff expenditure, with 
possible outsourcing and IT costs, one-off: 

ECHA: Staff 8.5 FTE (includes supervision of subcontracting); 
EUR 1 500 000 

EFSA: Staff 1.5 FTEs; EUR 320 000 

EEA: Staff 1.5 FTE 

EMA: Staff 1.5 FTEs 

EU-OSHA: Staff 0 FTEs 

JRC: see IPCHEM below; existing staff, EUR 60 000 per year, 
included in existing IPCHEM support 

Note: estimate includes any infrastructure -specific work related to 
the dedicated services of the common data platform.  

ECHA, 

EFSA, 

EEA, 

EMA, 
EU-
OSHA, 

COM 
incl. JRC 

Preparation for integration of selected 
datasets (1st time) 

Basic curation / profiling / metadata 

ECHA, 

Mapping and conversion to agreed 
formats, use of agreed substance 
identifiers, controlled vocabularies and 
tagging, quality control 

Confidentiality levels/user 
groups/filtering 

EFSA, 

EEA, 

EMA, 
EU-
OSHA 

Mechanisms for (periodic) ingestion by 
the platform; updates, versioning 

COM 
incl. JRC 

For dedicated services: preparation of 
datasets and functionalities 

Development by 2027; development duration 3 years for years 
2025, 2026, 2027, annual estimates of staff expenditure, with 
possible outsourcing and II costs, one-off: 

ECHA: Staff 1.5 FTE (includes supervision of subcontracting); 
EUR 170 000  

EFSA: Staff 3.5 FTEs; EUR 350 000 

EEA: Staff 1.5 FTE; EUR 200 000 

EMA: Staff 1.5 FTE; EUR 100 000 

EU-OSHA: Staff 0 FTE 

JRC: see IPCHEM below; existing staff, EUR 120 000 per year, 
included in existing IPCHEM support  

Note: estimate includes any dataset-ingestion specific work related 
to the dedicated services (preparation of all MVP identified 
services attributed to ECHA).  

Operation of the platform after 3-year 
development phase, including 
infrastructure costs after the go-live 

ECHA, 

Recurrent costs, annual estimates of staff expenditure and costs: 

EFSA, 

ECHA: Staff 4 FTE; EUR 600 000 

EEA, 

EFSA: Staff 2 FTE; EUR 500 000 

146 

 
 
  
  
 
 
 
 
 
 
 
 
  
  
 
EMA, 
EU-
OSHA 

COM 
incl. JRC 

EEA: Staff 1 FTE; EUR 200 000 

EMA: Staff 2 FTE; EUR 0 

EU-OSHA: Staff 0 FTE  

Note: IPCHEM would be fully integrated, the majority of its data 
managed by EEA, and part by ECHA.  

Also includes evolution for at least 1 low and 1 medium 
complexity project (see below).  

In total, the development of the platform and the integration of the datasets identified in the MVP is 
estimated  to  require  21  FTEs  and  ca.  EUR  2  823  000  annually  in  the  first  3  years,  and  recurrent 
operational requirements at the level of 9 FTEs and EUR 1 300 000 annually afterwards.  

Summary of additional resource needs for the common data platform on chemicals: 

Agency 

ECHA 

Summary of tasks 

EEA 

EFSA 

EMA 

EU - OSHA 

JRC 

Financial resource 
needs: 

Financial resource 
needs: 

2025: EUR 0 
2026: EUR 2 226 000 
2027: EUR 2 793 000 
2028: EUR 600 000 
Human resource needs:  2025:  4 TA, 6  CAs 
2026:  4 TA, 6  CAs 
2027:  4 TA, 6 CAs 
2028:  4 TA, 0 CAs 
2025: EUR 0  
2026: EUR 266 000 
2027: EUR 334 000 
2028: EUR 200 000 
Human resource needs:  2025: 1 TA, 2 CAs 
2026: 1 TA, 2 CAs 
2027: 1 TA, 2 CAs 
2028: 1 TA, 0 CAs 
2025: EUR 670 000 
2026: EUR 670 000 
2027: EUR 670 000 
2028: EUR 500 000 
Human resource needs:  2025:  0 TA, 5 CAs 
2026:  0 TA, 5 CAs 
2027:  0 TA, 5 CAs 
2028:  0 TA, 2 CAs 
2025: EUR 100 000 
2026: EUR 100 000 
2027: EUR 100 000 
2028: EUR 0 

Financial resource 
needs: 

Financial resource 
needs: 

Financial resource 
needs: 

Human resource needs:  2025:  0 TA, 3 CAs 
2026:  0 TA, 3 CAs 
2027:  0 TA, 3 CAs 
2028:  0 TA, 2 CAs 
2025: EUR 0 
2026: EUR 0 
2027: EUR 0 
2028: EUR 0 
Human resource needs:  2025:  0 FTE 
2026:  0 FTE 
2027:  0 FTE 
2028:  0 FTE 
2025: EUR 180 000 
2026: EUR 180 000 
2027: EUR 180 000 

Financial resource 
needs: 

147 

 
 
 
 
 
 
 
 
 
 
Future budget line: DG Environment, DG SANTE 

Candidate for fees: No 

2028: EUR 0 

20.  INFORMATION PLATFORM FOR CHEMICAL MONITORING (IPCHEM) 

Responsible body: 

Currently: Commission (JRC), EFSA and EEA 

(Re-)attribution planned to: ECHA (operation and maintenance of IPCHEM, hosting occupational 
monitoring data), EEA (for collecting and hosting human biomonitoring data (HBM), hosting 
environmental occurrence data and indoor air quality data), EMA (providing relevant data), EU-
OSHA (providing relevant data) 

Legal basis for (re-)attribution:  Proposal for a regulation of the European Parliament and of the 
Council establishing a common data platform on chemicals, laying down rules to ensure that the 
data contained in it are findable, accessible, interoperable and reusable and establishing a 
monitoring and outlook framework for chemicals 

Type of task: Existing 

Brief task overview: 

1.  Overall operation and maintenance of the Information Platform for Chemical Monitoring 

(IPCHEM) and provision of data to be shared via IPCHEM. 

2.  Collection and hosting of human biomonitoring data 
3.  Hosting of environmental occurrence data 
4.  Hosting of indoor air monitoring data 
5.  Hosting of occupational monitoring data 
6.  Providing relevant data  

Detailed process description:  

Current process: 

IPCHEM provides centralised, readily available and automated access to chemical monitoring data 
held by the European Commission, European agencies, Member State Bodies, Research Centres and 
Academic Institutions. It provides chemical monitoring data and information of defined quality in 
terms of spatial, temporal, methodological and metrological traceability as well as a reporting tool for 
chemical monitoring data (see https://ipchem.jrc.ec.europa.eu). 

IPCHEM is a functioning platform hosted and operated by JRC on request of DG ENV. EEA, EFSA 
and JRC are involved in the operation of the platform as module coordinators and as data providers. 
Work on IPCHEM is included in the work programme of the agencies. 

IPCHEM is currently structured into four thematic modules:  

-  Module for environmental occurrence data; 
-  Module for food and feed occurrence data; 
-  Module for human biomonitoring data; 
-  Module for product and indoor air data. It should be noted that for this module only the indoor 
air part is developed and populated with data; templates for metadata and data are developed.  

148 

 
 
 
 
As described in the IPCHEM governance paper, the IPCHEM governance framework involves many 
actors  with  multiple  roles,  who  are  involved  in  many  ways  at  different  levels,  requiring  strong 
interactions and collaboration.  

These actors are: Policy Lead, Scientific and Technical Lead, Module coordinators, Data providers 
and Partners/collaborators. 

JRC currently has the scientific and technical lead of IPCHEM, with the main responsibilities of: 

•  Developing and maintaining the IPCHEM platform infrastructure, functionality and 

security; 

•  Coordinating technical development and facilitating harmonisation (standardisation) of 

metadata and data reporting;  

•  Data integration and liaison with data providers; 
•  Contribution to exploitation of IPCHEM for policy priorities; 
•  Promoting IPCHEM by facilitating its use through technical guidance; 
•  Supporting and guiding module coordinators;  
•  Strategy formulation and priority setting. 

The four modules are coordinated by different actors, based on the best match of the thematic area 
with ongoing activities. Current coordinators are EFSA for food and feed, EEA for environment and 
human  biomonitoring  and  JRC  for  indoor  air  and  products.  The  responsibilities  of  the  module 
coordinators focus on:  

Identifying important data sets and data providers; 

• 
•  Supporting the evolution of metadata and data templates in the thematic area; 
•  Contributing to the utilisation of IPCHEM for addressing policy questions; 
•  Liaison with data providers; 
•  Promoting IPCHEM as policy/regulatory support tool. 

The table below describes the four categories of data included in IPCHEM, the associated data sources 
and updating frequency, actors involved in the data integration process outside the IPCHEM team, to 
which extent data formats are already harmonised and possible future entities to take care of these 
data flows: 

Standard formats 

Frequency of related requests 
to  integrate  such  data  into 
IPCHEM  

Future 
expected 
requests 

6 datasets with annual updates 
contributing  most 
the 
number of records in IPCHEM 

to 

Increasing 
number,  getting 
more structured 

Possible 
handling 
CDPC 
provider) 

future 
(EU-
data 

EU agencies 

Source 
data 

of 

Regular 
updates 

1  MS 

Yes 

2 

MS 

Yes 

Current 
players 
data 
handling 

in 

through 
agency 
(EEA, 
EFSA) 

Direct 
interaction 
with national 
agency 

Highly standardised 
for food and feed 

Standardised 
some 
extent 
environ. Data 

to 
for 

Well  managed  data 
sets  but 
in 
different formats 

all 

7 datasets with regular updates, 
contributing substantially to the 
number of records in IPCHEM 
+ 
and 
air 
occupational  monitoring  data* 
from MS in the pipeline  

indoor 

data 

EU agencies 

moving  more 
towards 
category  1  with 
these data 

149 

 
 
 
 
 
3  EU 

funded 

No 

research 
projects 

Individual 
projects 
or 
Cluster  level 
data WG 

Less  standardised, 
all  different;  but 
more 
reaching 
harmonisation 
in 
Clusters recently 

10  EU 
already 
projects 
included  +  4  new  large  EU 
projects  or  Clusters  in  the 
pipeline  

4  National  or 
regional 
research 
projects 

No  or  very 
low 
frequency 

Direct 
interaction 
with research 
organisation 

Less  standardised, 
all different 

~6 datasets 

(encouraged in the beginning to 
populate  IPCHEM,  now  not 
promoted any more) 

** 

at 
Remaining 
similar 
level, 
e.g.  an  average 
2-3 
research 
clusters 
supported 
parallel  

in 

** 

Decreasing 
trend, 
less 
relevant  for  the 
future 

Changes in the process: 

ECHA shall operate and maintain IPCHEM as part of the common data platform on chemicals. In 
addition,  ECHA  will  be  required  to  host  and  maintain  occurrence  data  related  to  workplace 
monitoring. 

EEA will be responsible for collecting and hosting the human biomonitoring data and for hosting 
environmental monitoring data and indoor air data currently collected or hosted by JRC as part of 
IPCHEM.  

IPCHEM will be integrated in the common data platform with its functionalities and data representing 
part of Minimum Viable Product. 

The required tasks are divided according to the container-content concept. The container considers 
the IPCHEM platform with its data management structure and user interface, while the content refers 
to the monitoring data contained in the four IPCHEM modules, based on data already included and 
on anticipated future data needs. 

Regarding the content, the four categories of data included in IPCHEM, the associated data sources 
and updating frequency, actors involved in the data integration process outside the IPCHEM team, to 
which extent data formats are already harmonised and possible future entities to take care of these 
data flows are shown in the table above. 

Regarding  the  container,  the  term  refers  to  the  IPCHEM  platform  with  its  architecture,  data 
management structures and user interface.  

In  the  process  of  integration  into  the  common  data  platform  on  chemicals,  the  data  management 
structure is considered separately from the user interface. 

1.  User interface: The current user interface of IPCHEM was built over many years, is difficult to 
maintain and also not entirely fit for purpose to address all relevant envisaged uses and search 
types of IPCHEM. 
It is  therefore proposed  to  re-build the user interface in  the context of the integration into the 
common data platform. The prototype user interface developed by the JRC IPCHEM team in June 
2022 should be considered as a starting point and to help estimate the resources needed. The new 
user interface implementation is  expected to  be driven by the  IPCHEM  and the  common data 
platform’s use cases involving monitoring (occurrence) data. 

2.  Data management structure: IPCHEM has a generalised structure, that aims to accommodate 
the  monitoring  data  regarding  different  media  and  coming  from  several  data  providers.  The 
current harmonisation process encompasses all the transformation steps required from the source 
data structure to the IPCHEM harmonized one. Two different record layouts are enforced, one for 
the individual measurement type of datasets and the other for the statistical type of datasets; in 
both  cases,  only  a  common  subset  of  the  data  is  harmonised,  and  quality  checked,  while  the 

150 

 
 
 
remaining  information  provided  are  encapsulated  as-is  into  a  generic  field  called  source  data, 
using the JavaScript Object Notation (JSON) format as a convenient yet flexible vehicle. 
IPCHEM  has  two  sub-systems:  IPCHEM  Portal  is  the  subsystem  providing  access  to  the 
harmonised and integrated data, while IPCHEM Share is the subsystem providing the file-sharing 
feature, compliant with the requirements defined by JRC Local Informatics Security Officer for 
the secure hosting of sensitive non classified data (e.g. two-factor authentication, encryption at 
rest, token secured application programming interface (API), etc.).  
It is advised to preserve this current structure of the system, in the transfer to the common data 
platform. The IPCHEM team is preparing detailed documentation and can support the hand-over. 

A 2-step approach is proposed as the most efficient way of integrating IPCHEM into the common 
data platform: 

1st phase (months 1-12): making monitoring data from IPCHEM findable via the common data 
platform, and preparatory work for functionality handover (co-work JRC/ECHA) 

Aims:  

- 

- 

- 

IPCHEM extended team contributes to the work on data, in particular the selection of substance 
identifiers and the selection of the supported format for inclusion of monitoring (occurrence) data.  
IPCHEM data contribution to the common data platform is analysed (data governance and policy) 
in accordance with the legislative proposal on data 
IPCHEM  extended team carries out  a study to  make metadata  and data  available in  IPCHEM 
more  FAIR,  including  harmonisation  of  module  specific  metadata  and  data  fields  with  the 
common data platform requirements (point above), including in the preparation for the anticipated 
future data providers to the platform for individual datasets 

-  Linking IPCHEM to the common data platform via metadata and substance identifiers; substance 
search will bring back links to IPCHEM datasets with the metadata description in agreed format22 
-  Analysis (container/functionality handover), identification of use cases, implementation planning 

Tasks 

1.  IPCHEM/EU-CDPC linking: 

a.  Analysis and design for the integration of: 

i.  Substance identity 
ii.  Harmonised metadata (common to all modules) 

b.  Implementation 

i.  Preparation of SID translation tables, metadata for IPCHEM datasets 
ii.  accessibility of harmonised metadata, as designed in [a.ii.](automated approach) 

c.  Testing 
d.  Maintenance/Servicing 

2.  Handover preparation IPCHEM/common data platform  

a.  Analysis and design: 

i.  Evaluation of the IPCHEM data governance within the common data platform 
(to/with platform data providers, existing IPCHEM datasets and future updates, 
possible use of DIGIT’s hosting facilities) 

ii.  FAIR evolution of the IPCHEM platform for better data harmonization and 

reuse: 

1.  Definition of harmonised formats including module specific metadata and 
data fields for monitoring (occurrence) data, part of joint WA3 initiative 
2.  Solution design for managing harmonised module specific metadata and 

data fields 

151 

 
 
iii.  Strategy definition for IPCHEM functionalities handover to the common data 

platform, including the secure sharing facilities (aka IPCHEM Share), the dataset 
integration software procedures, and identifying the user interface capabilities 
that are required by the platform's use cases involving monitoring (occurrence) 
data (possible use of DIGIT’s hosting facilities) 

b.  Governance aspects, data management 

Resource needs 1st phase 

•  Platform development (60K) 

o  1 developer full time for 8 months for complementing in IPCHEM the information 

and formatting required for the linking with the common data platform, in addition to 
what is already available in the public repository 
(https://ipchem.jrc.ec.europa.eu/public), or in the IPCHEM share subsystem 
(https://ipchem.jrc.ec.europa.eu/share via secure API); this encompasses possible 
enhancements (e.g. JSON-LD / RDF metadata format, DCAT-AP service, etc.) to 
make the system more FAIR; 

•  Handover preparation (120K) 

o  1 analyst, expert in chemicals monitoring in charge of supporting substance 

identification and metadata and data harmonisation (in close collaboration with 
module coordinators) for 12 months  

o  1 regulatory expert to prepare the adoption of more harmonised formats and perform 
impact assessment (on the common data platform, data providers and modules 
coordinators) for 12 months 

2nd phase (months 12-36): IPCHEM full integration into the common data platform 

Aims:  

IPCHEM functionalities are gradually handed over to the platform 

-  Single interface to IPCHEM data through common data platform 
- 
-  A new governance is put in place incorporating harmonisation and regulatory updates 
-  Data flow is established between the data providers (agencies) and the platform  

Tasks 

1.  Supporting the common data platform occurrence data governance implementation and 

IPCHEM functionalities transfer to the platform 

a.  Data Management 

i.  Defining a new data governance 
ii.  Defining a new data policy 
iii.  Planning IPCHEM data management handover 

b.  Implementation 

i.  Supporting the implementation of IPCHEM functionalities in the platform, 

including the rebuilding of the user interface with up-to-date technologies, to best 
address the platform's uses cases involving the monitoring (occurrence) data; 

ii.  Implementing IPCHEM data management handover 

c.  Testing 
d.  Maintenance/Servicing 

i.  Provisioning of support to data providers for transitioning to platform data 

submission 

2.   Implementing more rich and FAIR metadata and data formats 

a.  Supporting ECHA in the design 

152 

 
 
3.   Implementing business analytics features, starting from the platform’s use cases involving the 

monitoring data  

a.  Supporting ECHA in the design 

Resource needs 2nd phase 

•  Platform development (100K) 

o  1 developer full time for 18 months for fully integrating IPCHEM metadata and data 

into the common data platform   

•  Dataset preparation (220K) 

o  1 data analyst, expert in chemicals monitoring, in charge of enhancing the IPCHEM 
metadata and data formats (i.e. to make metadata and data more rich and FAIR), for 
24 months 

o  1 regulatory expert to prepare full transfer of the data management process (data 

policy, governance, data flows, etc.), for 18 months 

Proximity to agencies’ mandate:  

-  While  ECHA’s  core  mandate  is  focused  on  the  safety  assessment  of  chemicals,  ECHA’s 
mandate  includes  the  dissemination  of  information  on  chemicals.  A  better  sharing  of  data 
between EU authorities can contribute to the success of ECHA’s core mandate. As ECHA is 
tasked to operate the common data platform on chemicals, the operation of IPCHEM and its 
integration into that platform fit well with ECHA existing tasks.  

-  EEA  already  acts  as  a  module  coordinator  for  human  biomonitoring  and  thus  hosting  of 
human  biomonitoring  data  would  fit  with  the  existing  mandate  of  EEA.  Hosting  human 
biomonitoring data, environmental monitoring data and indoor air quality data fits well into 
EEA work on human health and the environment, as the data provides a good basis for the 
assessment of environmental impacts on human health.  

-  ECHA is currently performing scientific assessments underpinning the setting of occupational 
exposure limit values so hosting occupational monitoring data fits well with its mandate.  

Projected synergies and added value of (re-)attribution: 

Type 

Synergies 

Reuse of 
capabilities 

High 

Process and expertise:  

ECHA already supports similar work on data dissemination under 
REACH and other legislation. ECHA is also tasked to develop and 
operate the common data platform on chemicals. Several key 
capacities can be reused/reinforced: 

- 

- 

IT capabilities for data integration and public and 
confidential data dissemination  
IT capabilities for data submission and publication of 
regulatory intentions 

-  Development and operation of the common data platform on 

chemicals  

EEA already hosts environmental occurrence data and has a deep 
expertise in collecting and hosting the data. 

Re-use of data  N/A 

N/A 

Workload 
balancing 

Low 

With the IT development work clearly defined in a 3-year project 
plan and after that a running phase with much less resources, there 
is a clear resource plan and little or no room for workload balancing 

153 

 
 
(and resource estimates are already annualised). 

High 

Reuse of IT, reporting and hosting capabilities.  

High 

Reuse of scientific support services and of administrative services. 

IT tools: 
automation 
and economies 
of scale 

Support 
services: 
economies of 
scale 

Projected impact on agencies 

•  Committees/bodies:  low  impact.  The  task  does  not  require  involvement  of  agencies’ 
committees /bodies. EEA might use their networks for collecting human biomonitoring data  
•  Data model and IT infrastructure: high impact. The task requires investment in data structures 

and IT systems/capabilities 

•  Key  experts:  high  impact.  The  task  heavily  relies  on  expert  competencies,  but  these  are 

present in the agencies.  

Workload and resource implications: 

Current workload and resource use: 

JRC has a total of 4.5 FTE (2.5 JRC staff, 2 external consultants intramuros) assigned to the IPCHEM 
operation. There are also resources allocated to the contribution to IPCHEM in the work programmes 
of EFSA and EEA.  

The current resources spent by the Commission can be summarized as follows: 

DG JRC  

4.5 FTE per year (2.5 JRC staff and 2 external 
consultants intramuros) 

Yearly IT maintenance costs from JRC 
corporate hosting facility 

EUR 11 700 per year 

Total 

4.5 FTEs annually 

Current budget line: DG JRC institutional work programme 

Future workload and resource use:  

The integration of IPCHEM into the common data platform, the continuous provision of data by the 
agencies to the IPCHEM and coordination/cooperation among the agencies is included in the resource 
estimates under the common data platform on chemicals. The integration will be done jointly by JRC 
and ECHA. ECHA will take over the operation of IPCHEM from JRC and will take over hosting of 
occupational monitoring data. For this ECHA will need 2 FTEs. In addition, EEA will take over from 
JRC  collection  and  hosting  of  human  biomonitoring  data  and  hosting  of  IPCHEM  environmental 
occurrence  data  and  indoor  air  monitoring  data.  For  this,  EEA  will  need  1  FTE  per  year.    EFSA 
already provides data to IPCHEM and contributes to its operation and will not require any additional 
resources to continue in this activity. EMA and EU-OSHA currently do not systematically collect or 
receive data relevant for IPCHEM and therefore will not require any additional resources. 

Summary  of  resource  needs  for  maintaining  IPCHEM  and  its  parts  after  its  integration  into  the 
common data platform on chemicals: 

154 

 
 
 
 
Agency 

Summary of tasks 

ECHA 

Operation and development of IPCHEM  

Collecting and hosting  occupational monitoring 
data 

Financial resource 
needs: 

Human resource 
needs: 

EEA 

Collecting and hosting human biomonitoring data, 
developing a data model and creating a reporting 
structure to host human biomonitoring data.  

Financial resource 
needs: 

Hosting indoor air data 

Collecting and hosting environmental occurrence 
data 

Human resource 
needs: 

Provision of occurrence data 

Cooperation and coordination on IPCHEM 

Financial resource 
needs: 

Human resource 
needs: 

EFSA 

EMA 

EU-
OSHA 

2025: EUR 0 
2026: EUR 0 
2027: EUR 180 000 
2028: EUR 180 000 
2025:  0 TA, 0 CAs 
2026:  1 TA, 1 CAs 
2027:  1 TA, 1 CAs 
2028:  1 TA, 1 CAs 
2025: EUR 0 
2026: EUR 200 000  
2027: EUR 200 000 
2028: EUR 50 000 
2025:  1 TA, 0 CAs 
2026:  1 TA, 0 CAs 
2027:  1 TA, 0 CAs 
2028:  1 TA, 0 CAs 
2025:  EUR 0 
2026:  EUR 0  
2027:  EUR 0 
2028:  EUR 0 
2025:  0 FTEs 
2026:  0 FTEs 
2027:  0 FTEs 
2028:  0 FTEs 

Future budget line: DG Environment  

Candidate for fees: No 

21.  INFORMATION ON REGULATORY PROCESSES ON CHEMICALS 

Responsible body: 

Currently: ECHA (existing (P)ACT), EFSA (existing OpenEFSA) 

(Re-)attribution planned to: ECHA, EFSA EEA and, EU-OSHA 

Legal basis for (re-)attribution:  Proposal for a regulation of the European Parliament and of the 
Council establishing a common data platform on chemicals, laying down rules to ensure that the data 
contained in it are findable, accessible, interoperable and reusable and establishing a monitoring and 
outlook framework for chemicals 

Type of task: Existing but expanded to cover all chemical sectors 

Brief task overview: (1) Operating (public) activities coordination tool; (2) notifying relevant 
information to the (public) activities coordination tool  

Detailed process description:  

Current process: 

The Activities Coordination Tool and its public counterpart, (P)ACT, are two existing information 
systems developed and operated by ECHA which provide an up-to-date overview of all planned and 
ongoing initiatives on chemicals by authorities under REACH and CLP. The information is provided 
in  user-friendly  tables  and  is  regularly  updated.  The  information  is  provided  by  authorities  and 
includes  information  on  authorities'  actions  (intention/on-going/finalisation)  relevant  for  an 
assessment process. 

155 

 
 
 
 
 
 
ACT  helps  authorities  to  coordinate  their  work  by  providing  information  on  planned,  ongoing  or 
completed  substance-specific  activities.  PACT  (public  ACT)  ensures  transparency  of  regulatory 
safety  assessment  work.  It  gives  the  public  an  ‘early  warning’  of  the  substances  that  are  on  an 
authority’s radar for exploring the need for regulatory risk management and provides a more holistic 
picture of what is going on under different regulatory processes. The processes and legislation already 
covered by (P)ACT are indicated in the table below. 

Through a recent project, ECHA reviewed the tool to improve its efficiency and functionality and to 
allow extension to further processes under its remit.  

EFSA,  as  part  of  their  existing  activities,  also  provide  some  level  of  digital  transparency  on  their 
planned, ongoing and concluded assessments, as part of their general OpenEFSA portal. The portal 
provides  access  to  information  related  to  EFSA's  scientific  work,  tracking  of  the  risk  assessment 
process from receipt of a dossier to adoption of the opinion. Information available includes: status of 
assessments, dossiers and studies, meeting agendas and minutes, information on experts (DOIs) and 
public consultations. The OpenEFSA portal is similar to PACT. The OpenEFSA portal does not have 
a confidential ‘ACT’ part. The processes and legislation already covered by OpenEFSA are indicated 
in the table below. 

Metadata and formats behind both IT tools are not easily comparable, but a lot of work has already 
been  put  in  the  organisation  of  this  information  and  in  building  processes  to  keep  updating  the 
systems.  

Changes in the process: 

To promote the coordination of safety assessment activities across EU legislation, the ‘one substance, 
one  assessment’  approach  considers  progressively  expanding  the  existing  (P)ACT  from  including 
REACH and CLP regulations to including all relevant chemicals legislation with safety assessment 
processes and initiatives. 

ECHA will operate an extended (P)ACT service, starting with a similar functionality of the existing 
tool but addressing processes across all the sectors where chemical assessments are performed. ECHA 
will provide relevant information into (P)ACT for all the processes from legislation for which ECHA 
is or will be an assessment body. EFSA will provide to ECHA for integration into (P)ACT the relevant 
information for all the processes from legislation for which EFSA is an assessment body and that are 
already  covered  in  the  OpenEFSA  portal.  In  other  words,  EFSA  is  toensure  that  OpenEFSA 
information feeds into the (P)ACT and is further complemented for confidential part on intentions, 
where relevant. Finally, EEA and EU-OSHA will provide to ECHA for integration into PACT any 
relevant information for the process from legislation for which EU-OSHA is an assessment body. 
The processes and legislation to be included in the extended (P)ACT are identified in the table below. 
The  extended  (P)ACT  will  be  available  as  a  specific  service  under  the  common  data  platform 
(dedicated service on ‘information on regulatory processes on chemicals’), with the identification of 
individual processes as well as associated datasets (starting with substance identification) covered by 
the  controlled  vocabularies.  The  service  will  maintain  the  differentiated  authorities/public  access, 
with up-to-date public information on declared registries of intent, status of assessment in progress 
and  outcomes  (including  documentation)  once  concluded.  Authorities  will  have  access  to  further 
categories and datasets for informing on preliminary intent supporting exchange and coordination as 
appropriate, and where relevant access to working material during the process. The governance will 
be done through the governance of the common data platform on chemicals. 

To  control  complexity,  a  solution  as  regards  the  update  of  the  information  in  the  platform, 
maintenance  of  relevant  lists,  metadata  and  supporting  datasets  will  need  to  be  prepared  by  the 

156 

 
 
agencies involved as principal actors in particular processes, even for cases where further actors may 
be involved or even ultimately responsible for the process outcome (e.g. national authorities).  

Overview  of  legislation  and  processes  included  or  to  be  included  in  (P)ACT  (referred  to  as 
‘information  on  regulatory  processes  on  chemicals’  as  the  dedicated  service  in  the  common  data 
platform on chemicals): 

Legislation 

Legislation already covered in (P)ACT 

(EC) 

1907/2006 

the 
Regulation 
concerning 
Registration,  Evaluation,  Authorisation 
and 
Restriction  of  Chemicals  (REACH),  establishing  a 
European Chemicals Agency 

Regulation (EC) 1272/2008 on classification, labelling 
and  packaging  of  chemicals  of  substances  and 
mixtures  

Processes already 
covered or to be 
included in ACT 

(ACT covers also 
intentions) 

Processes already covered 
or to be included in PACT 

(PACT covers the ongoing 
processes) 

- Screening 
 - Dossier evaluation 
 - Substance evaluation 
 - ED, PBT 
identification 
 - RMOA 
 - SVHC identification 
 - Annex XIV 
 - Application for 
authorisation 
 - Restriction 

- 
 - Dossier evaluation 
 - Substance evaluation 
 - ED, PBT identification 
 - RMOA 
 - SVHC identification 
 - 

- 

- Restriction 

- CLH 

- CLH 

Regulation  (EU)  2019/1021  on  persistent  organic 
pollutants 

- 

- Proposal for listing 
 - Limit values (UTC, low 
POP content) 

Legislation for which discussions for inclusion in (P)ACT are ongoing  

Regulation (EU) No 528/2012 concerning the making 
available on the market and use of biocidal products  

 Discussions are ongoing: 

- Evaluation of active substance 

Legislation identified to be included in (P)ACT and for which ECHA is or will be an assessment body  

- Opinion of BPC on active substance approval 

Directive  2004/37/EC  on  the  protection  of  workers 
from the risks related to exposure to carcinogens or 
mutagens at work 

- Setting EU OELs;  

- Setting national OELs 

Directive 98/24/EC on the protection of workers from 
the risks related to chemical agents at work 

Directive  2009/148/EC  on  the  protection  of  workers 
from the risks related to exposure to asbestos  

- Setting EU OELs 

- Setting national OELs 

- Setting new EU OELs 

Stockholm  Convention  on  persistent  organic 
pollutants 

- Intention to nominate a substance as POP 

157 

 
 
Directive 2011/65/EU on the  restriction of the use of 
in  electrical  and 
certain  hazardous  substances 
electronic equipment 

- Review of exemptions 

Directive 2000/53/EC on end-of life vehicles 

- Review of exemptions 

Proposal  for  a  Regulation  concerning  batteries  and 
waste batteries 

- Restriction process 

Directive  2008/105/EC  on  environmental  quality 
standards in the field of water policy 

- EQS derivation EU and national 
 - addition/removal of substance to watch list 

Directive  2006/118/EC  on 
groundwater against pollution and deterioration 

the  protection  of 

- Limit value derivation EU and national? 
 - Addition/removal of substance to watch list 

Directive  (EU)  2020/2184  on  the  quality  of  water 
intended for human consumption 

- Safety assessment of contact materials 

Regulation (EC) No 1223/2009 on cosmetic products 

- Safety assessment; 

Directive 2009/48/EC on the safety of toys 

- Safety assessment; 

Legislation identified to be included in (P)ACT and for which EFSA is an assessment body and information is 
included in OpenEFSA 

Regulation (EC) No 178/2002 laying down the general 
principles and requirements of food law, establishing 
the European Food Safety Authority and laying down 
procedures in matters of food safety 

- To be included (relevant processes to be identified) 

Regulation  (EC)  No  1935/2004  on  materials  and 
articles intended to come into contact with food  

- Safety assessment 

-  Commission Regulation (EU) No 10/2011 on 
plastic materials and articles intended to come 
into contact with food  

-  Commission Regulation (EC) No 450/2009 on 
active and intelligent materials and articles 
intended to come into contact with food  
-  Commission Regulation (EC) No 282/2008 on 
recycled plastic materials and articles intended 
to come into contact with foods  

-  Commission Directive 2007/42/EC relating to 
materials and articles made of regenerated 
cellulose film intended to come into contact 
with foodstuffs  

-  Commission Regulation (EU) 2018/213 on the 
use of bisphenol A in varnishes and coatings 
intended to come into contact with food  
-  Commission Regulation (EC) No 1895/2005 
on the restriction of use of certain epoxy 
derivatives in materials and articles intended to 
come into contact with food 

Council Directive 84/500/EEC on the approximation of 
the laws of the Member States relating to ceramic articles 
intended to come into contact with foodstuffs 

Commission Directive 93/11/EEC concerning the release 
of  the  N-nitrosamines  and  N-  nitrosatable  substances 
from elastomer or rubber teats and soothers 

158 

 
 
Regulation (EC) No 1331/2008 establishing a common 
authorisation  procedure  for  food  additives,  food 
enzymes and food flavourings  

- Safety assessment 

Regulation (EC) No 1333/2008 on food additives 

Regulation (EC) No 1332/2008 on food enzymes 

Regulation  (EC)  No  1334/2008  on  flavourings  and 
certain  food  ingredients  with  flavouring  properties 
for use in and on foods 

-  Commission Regulation (EU) No 234/2011 

implementing Regulation (EC) No 1331/2008 
establishing a common authorisation procedure 
for food additives, food enzymes and food 
flavourings 

Directive  2009/32/EC  on  the  approximation  of  the 
laws of the Member States on extraction solvents used 
in the production of foodstuffs and food ingredients 

- Safety assessment 

Council  Regulation  (EEC)  No  315/93  laying  down 
Community procedures for contaminants in food 

- Safety assessment   

-  Commission Regulation (EC) No 1881/2006 

setting maximum levels for certain 
contaminants in foodstuffs 

-  Commission Implementing Regulation (EU) 
No 884/2014 imposing special conditions 
governing the import of certain feed and food 
from certain third countries due to 
contamination risk by aflatoxins 

-  Commission Regulation (EC) No 401/2006 

laying down the methods of sampling and 
analysis for the official control of the levels of 
mycotoxins in foodstuffs  

-  Commission Regulation (EC) No 333/2007 

laying down the methods of sampling and 
analysis for the official control of the levels of 
lead, cadmium, mercury, inorganic tin, 3-
MCPD and benzo(a)pyrene in foodstuffs 
-  Commission Regulation (EU) 2017/644 laying 
down methods of sampling and analysis for the 
control of levels of dioxins, dioxin-like PCBs 
and non-dioxin-like PCBs in certain foodstuffs  

-  Commission Regulation (EC) No 1882/2006 

laying down methods of sampling and analysis 
for the official control of the levels of nitrates 
in certain foodstuffs 

Directive  2002/32/EC  on  undesirable  substances  in 
animal feed 

- Safety assessment 

Regulation (EC) No 1107/2009 concerning the placing 
of plant protection products on the market 

- Safety assessment as part of the substance (re-)approval 
process 

Regulation  (EC)  No  396/2005  on  maximum  residue 
levels of pesticides in or on food and feed of plant and 
animal origin 

- Safety assessment as part of the reviewing, amending, 
setting, deleting of MRLs 

Regulation (EC) No 1831/2003 on additives for use in 
animal nutrition 

- Safety assessment 

159 

 
 
  
  
  
-  Commission Regulation (EC) No 429/2008 on 
detailed rules for the implementation of 
Regulation (EC) No 1831/2003 as regards the 
preparation and the presentation of applications 
and the assessment and the authorisation of 
feed additives 

Proximity to the mandate of agencies: for ECHA very high, as it developed and operated the tool, 
and is designated as the manager of the common data platform in the future. For EFSA very high, as 
EFSA already operates the OpenEFSA portal.   

Projected synergies and added value of reattribution: 

Synergies come from the fact that one system or dedicated service can serve multiple agencies. The 
added value of the system is that all agencies and stakeholders will be able to find out at one place 
about the ongoing or planned regulatory processes on substances.  The development of the dedicated 
service on information on regulatory processes on chemicals (I.e. extended PACT) will be done as 
part of the development of the common data platform on chemicals, exploiting the same governance 
process and building blocks required.   

Main risks and opportunities:  

The  development  of  an  all-encompassing  controlled  vocabulary  and  rules  for  all  the  different 
contributors will be extensive. It is however not considered a risk as all processes are individually 
well  controlled  by  the  agencies  responsible  for  the  implementation  of  the  individual  pieces  of 
legislation.  Risks  are  mitigated  by  the  designated  role  of  the  agencies.  The  dedicated  service  on 
information  on  regulatory  processes  on  chemicals  provides  a  major  opportunity  to  facilitate  the 
coordination  between  the  assessments  and  reuse  of  assessments  performed  elsewhere,  to  avoid 
duplication of work and to save time when informed decisions on further management actions can be 
taken. 

Projected impact on agencies 

•  Committees/bodies: no impact. The task does not require the involvement of committees 
/bodies (with the exemption of their secretariat that will be the main provider of respective 
information from the committees to the dedicated service on information on regulatory 
processes, as is the case now for PACT) 

•  Agencies’ data model and IT infrastructure: high impact. The same considerations apply as 
for the development of the common data platform in its entirety. The data models of 4 agencies 
for this type of information will have to be aligned.  

•  Agencies’ key experts: no impact. The task does not require a specific expertise. The task is 

effectively just a reporting/documenting of the processes.  

Projected workload and resource implications: 

Future workload and resource needs:  

Work description   

Who   

Resource needs estimate  

Developing the dedicated service on 
information on regulatory processes 
on chemicals as part of the common 
data platform  

Designing and developing the dedicated 
service’s data structure, functionalities 
and IT service.   

ECHA  

See common data platform estimates: preparation of the 
dedicated service on information on regulatory processes on 

160 

 
 
  
  
Notably most of the building blocks of 
existing ECHA (P)ACT can be reused. 
Experiences from similar portals like 
OpenEFSA from other agencies need to 
be included. Proper consideration must 
be given to the service’s functioning 
through differentiated access 
(agencies/public) and the ability to 
efficiently (albeit within constraints) 
serve during transitional periods while 
legal provisions on sharing between 
agencies are still being adopted.   

chemicals is already included in the estimate as part of MVP 
basic IT infrastructure.  

The dedicated service is expected to be included already in the 
first demo at T0+12 months, likely with limited coverage of 
processes included (ECHA, EFSA). Full functionality is expected 
in the goLive version in 2028.   

Cooperation with and providing input to 
ECHA for the development of the 
dedicated service on information on 
regulatory processes on chemicals (as 
part of the common data platform 
governance) 

EFSA,  
EEA,  
EU-OSHA,  
COM  

Contribution expected by  EFSA, EEA, EU-OSHA and COM to 
help identify structure and functionalities, also on the basis of 
own experiences and expected needs. Ideally covered by the 
agencies’ core staff but can include external IT expertise in 
particular when one was covering existing solutions. Resources 
should be absorbed by the agencies  as part of the resources 
assigned to the development of the common data platform. 

Based on common agreements, 
preparation of internal dataflows, 
packaging of regulatory processes 
information and supporting ingestion 
into the common data platform  

ECHA, 
EFSA, 
EEA,  
EU-OSHA 
COM  

ECHA will have to integrate the remaining data flows for 
legislation not yet included in the current PACT. This is covered 
by the resources allocated as part of the proposals which 
reattributes certain processes to ECHA and which should be 
included in PACT.  

Provision of regulatory information  

Keeping the dedicated service on 
information on regulatory processes on 
chemicals up-to-date by recurrent 
ingestion of new information and 
revision of existing one.  

ECHA, 
EFSA, 
EEA,  
EU-OSHA 

The processes may include other actors 
than the agencies (e.g. competent 
authorities), however agencies would be 
responsible for packaging the 
information and linking with ECHA’s 
platform, in a consistent manner. 

Providing ‘legacy regulatory 
information’ (i.e. information already 
available before entry into force of the 
regulation establishing the common data 
platform) 

ECHA, 
EFSA,  
EMA  

EFSA already have the data flows developed. They might need to 
be amended and retargeted to feed into the dedicated service on 
information on regulatory processes on chemicals. 

EEA, EU-OSHA will need to develop data flows and integrate 
them into the dedicated service.  

Resource needs are covered in the estimation for the operation of 
the common data platform 

While it is anticipated that the internal dataflows will reflect 
agreements on common metadata on processes, resulting in little 
overhead in order to ‘package’ for the platform, some additional 
resources will be required. The extent depends on the number of 
processes initiated (and should therefore be covered within 
proportionate IT overhead in case additional tasks are attributed 
to an agency), and to a degree the level of detail regarding 
information on intermediate steps and data to be associated.  

A general estimate of basic information is considered in the 
estimate for common data platform operations – no further 
resources are included here.  

It is considered that information already provided in some 
structure on respective IT platforms will be able to be introduced 
into the dedicated service on information on regulatory processes 
on chemicals. This would be achieved in a progressive way (with 
prioritization) but should be achieved with resources covered by 
the common data platform operation.  

161 

 
 
 
  
  
  
  
 
Overview of resource needs per agency for the operation of the dedicated service on information on 
regulatory processes on chemicals: 

Agency 

Summary of tasks 

ECHA 

Designing and developing the dedicated service’ data 
structure, functionalities and IT service. 

Operating the dedicated service as part of the common 
data platform on chemicals 

Financial 
resource 
needs: 

Based on common agreements, preparation of internal 
dataflows, packaging of regulatory processes 
information and supporting ingestion into the 
common data platform 

Human 
resource 
needs: 

Included as part of the 
common data platform on 
chemicals + to be absorbed as 
part of the individual 
regulatory processes 
Included as part of the 
common data platform on 
chemicals + to be absorbed as 
part of the individual 
regulatory  processes 

EEA 

EU-OSHA 

Keeping the dedicated service up-to-date by recurrent 
ingestion of new information and revision of existing 
one. 

Providing ‘legacy regulatory information’ 

Cooperation with and providing input to ECHA for 
the development of the dedicated service 

Based on common agreements, preparation of internal 
dataflows, packaging of regulatory processes 
information and supporting ingestion into the 
common data platform 

Keeping the dedicated service up-to-date by recurrent 
ingestion of new information and revision of existing 
one. 

EFSA 

Providing ‘legacy regulatory information’ 
Cooperation with and providing input to ECHA for 
the development of the dedicated service 

Based on common agreements, preparation of internal 
dataflows, packaging of regulatory processes 
information and supporting ingestion into the 
common data platform 

Keeping the dedicated service up-to-date by recurrent 
ingestion of new information and revision of existing 
one. 

Providing ‘legacy regulatory information’ 

Future budget line: As part of the agencies’ budgets  

Candidate for fees: No 

22.  REPOSITORY OF REFERENCE VALUES 

Responsible body:  

Financial 
resource 
needs: 

Human 
resource 
needs: 

Financial 
resource 
needs: 

Human 
resource 
needs: 

EEA and EU-OSHA are 
currently not involved in any 
processes relevant for the 
database, therefore no 
resources are required for 
them.  

Included as part of the 
common data platform on 
chemicals + to be absorbed as 
part of the individual 
regulatory processes 

Included as part of the 
common data platform on 
chemicals + to be absorbed as 
part of the individual 
regulatory processes 
Included as part of the 
common data platform on 
chemicals + to be absorbed as 
part of the individual 
regulatory processes 

Currently: ECHA (some reference values as part of EUCLEF), EFSA (some reference values as part 
of  open  food  tox  database),  Commission  –  DG  SANTE  (some  reference  values  as  part  of  the 
pesticides database)  

(Re-)attribution planned to: ECHA, EFSA, EMA, EU-OSHA [and Commission – DG SANTE]  

Legal basis for (re-)attribution:  Proposal for a regulation of the European Parliament and of the 
Council establishing a common data platform on chemicals, laying down rules to ensure that the data 

162 

 
 
 
 
 
 
 
 
 
contained in it are findable, accessible, interoperable and reusable and establishing a monitoring and 
outlook framework for chemicals 

Type of task: Existing but extending the scope and centralizing the reference values in one 
repository  

Brief task overview: Setting up and operating a centralized repository of reference values derived or 
collected  as  part  of  the  implementation  of  Union  chemicals  legislation  or  on  the  request  of  the 
Commission also those provided by the Member States or international organization.   

Detailed process description:   

Current process:  

EFSA has developed and is maintaining the OpenFoodTox database1. It is a structured database (Exel 
sheet) summarising the outcomes of all hazard identification and characterisation for human health 
(plant  protection  products,  food  improvement  agents,  and  contaminants),  animal  health  (feed 
additives,  pesticides  and  contaminants)  and  the  environment  (feed  additives  and  pesticides) 
performed by EFSA. OpenFoodTox provides information on substance identity and characterisation, 
links to EFSA’s related output, relevant background EU legislation, and a summary of the critical 
toxicological endpoints and reference values for the substance. The data model of OpenFoodTox has 
been designed using an OECD Harmonised Template (OHT) as a basis to collect and structure the 
data in a harmonised manner. The database is being populated by an external contractor who extracts 
the  relevant  information  from  the  EFSA  opinions.  The  database  contains  scientific  values  from 
EFSA’s opinions. Currently, relevant information from all opinions delivered by EFSA is  already 
included in the database and EFSA continues updating the database.  

The EU pesticides database2 is the official source for pesticide Maximum Residue Levels (MRLs) in 
food products. It is maintained by the Commission – DG SANTE - and it contains both the current 
and  historical  information  on  MRLs  of  pesticides  with  the  residue  definition  and  a  coded  list  of 
commodities to which the MRLs apply. The database contains regulatory reference values from the 
relevant legislation. The Commission – DG SANTE - continues updating it.   

ECHA has developed and operates the EU Chemicals Legislation Finder (EUCLEF)3. It is an online 
service to access an overview of 56 pieces of EU chemicals legislation. The purpose of EUCLEF is 
to offer users the possibility to navigate through the EU chemicals legislative framework and find 
relevant information on how substances are regulated across the EU. EUCLEF was developed to help 
companies  who  need  to  track  their  obligations  across  different  EU  laws.  EUCLEF  lists  some 
regulatory reference values derived and applicable under these legislative pieces. There might be an 
overlap between information in EUCLEF and in the EU pesticides database.   

Changes in the process:  

ECHA establishes and operates the centralized EU repository of reference values as part of a database 
with information on the provisions and legal obligations applicable to chemicals under the Union acts 
by adapting the existing EUCLEF system (see section 23). Both the repository of reference values 
and  a  dedicated  service  on  information  on  the  obligations  under  EU  acts  on  chemicals  (i.e.  an 
expanded EUCLEF system) are established as part of the common data platform and the governance 
structure of the platform is also used to govern the development and operation of the repository of 
reference values.  

ECHA makes available in the repository all regulatory reference values adopted under EU chemicals 
legislation (this is broader than today and contains more metadata information).  

163 

 
 
ECHA extracts and feeds into the repository all ‘legacy scientific reference values’ from ECHA’s 
opinions  (i.e  all  reference  values  already  derived  by  ECHA  before  the  entry  into  force  of  the 
regulation  establishing  the  common  data  platform  and  which  are  not  formally  adopted  under  EU 
legislation). For ‘new reference values’ ECHA starts providing reference values on a continuous basis 
to the repository as new opinions are adopted by ECHA.   

EFSA provides the collection of ‘legacy scientific reference values’  (i.e. those which are not formally 
adopted  under  EU  legislation  but  derived  by  EFSA)  from  the  Open  Food  Tox  to  ECHA  to  be 
integrated in the repository. For ‘new scientific  reference values’  (i.e. those that are not formally 
adopted under EU legislation but derived by EFSA) EFSA continues providing relevant information 
on a continuous basis to the repository (or to ECHA) as new opinions are adopted by EFSA.  

The Commission – DG SANTE - continues to operate and populate the EU pesticide database with 
new regulatory reference values. The Commission  – DG SANTE - establishes a dynamic link for 
provision of the information from the EU pesticide database to ECHA to be made available also via 
the repository.   

EMA  provides  on  a  continuous  basis  to  ECHA  all  new  (i.e.  adopted  after  entry  into  force  of  the 
regulation  establishing  the  common  data  platform)  predicted  no  effect  concentrations  (PNECs) 
derived as part of the environmental risk assessment under Directive 2001/83/EC, Regulation (EC) 
No 726/2004 and Regulation (EU) 2019/6  

EEA and EU-OSHA provide on a continuous basis to ECHA all new scientific reference values they 
might derive in the future, as currently they do not do so.  

The governance of the common data platform is used for governing the development and operation 
of the repository.   

Proximity to agencies’ mandate:  

The  tasks  fit  well  with  the  mandate  of  each  agency.  EFSA,  ECHA  and  EMA  provide  scientific 
reference  values  from  the  assessments  they  perform.  ECHA  is  already  operating  EUCLEF  and  is 
tasked to operate the common data platform, so for ECHA it is an extension of its current work.   

Projected synergies and added value of (re-)attribution:  

Operating  only  one  repository  of  reference  values  compared  to  several  separate  ones  will  save 
resources. The existing IT solution and contractual arrangement available in ECHA can be reused.   

Main risks and opportunities: There might be an overlap between reference values in the repository 
and in the EU pesticide database.  

Projected impact on agencies  

-  ECHA/EMA/EFSA committees/bodies:  low impact. The rapporteurs of opinions  might be 
asked to extract the reference values and metadata for integration into the repository as part 
of the finalisation of the opinion.   

-  ECHA data model and IT infrastructure: medium impact. The task requires adaptation of the 

EUCLEF IT solution.   

-  EMA/EFSA data model and IT infrastructure: low impact. EMA and EFSA would use the 
data  model  set  by  the  repository.  They  would  be  reusing  the  IT  solution  provided  by 
ECHA.  ECHA/EMA/EFSA key experts: low impact. Experts are needed to extract relevant 
information from the opinion into the repository.   

Projected workload and resource implications:  

Work description   

Who    Resource needs estimate  

164 

 
 
Setting up the repository on the basis of 
EUCLEF  

Designing and developing the repository 
as expansion of EUCLEF and as part of 
the common data platform   

Coordination of and consultation with 
other agencies contributing to the 
repository (as part of the common data 
platform) during development  

ECHA   Development by 2028; development duration 3 years (years 2025, 

2026, 2027)  
One-off costs for contracting the development (to supplement IT 
costs of EUCLEF):   

- 
- 
- 

2025: EUR 0 
2026: EUR 550 000  
2027: EUR 550 000  

The IT development can be subcontracted but it will need to be 
overseen/supervised by ECHA staff. The development is to be 
coordinated with other agencies.   

Estimated coordination for the development phase (2025-2027): 1 
FTE per year 

Contribution to the development phase    

EMA, 
EFSA, 
EEA,  
EU-
OSHA 
COM  

negligible; should be absorbed by the agencies  

Operating the repository as part of 
EUCLEF  

Operation/hosting, maintenance and 
update of the repository as part of  
EUCLEF and as part of the common data 
platform   

Coordination of and consultation with 
other agencies contributing to the 
repository (as part of the common data 
platform governance)  

ECHA   Recurrent costs as of 2028: EUR 200 000 and 1 FTE per 

year. This is to cover the improvements and maintenance of the 
repository as part of the EUCLEF and the common data platform, 
contact with data providers, covering specific needs of the 
repository  

Recurrent resource ideally covered by the agencies’ core staff.   

Negligible; should be absorbed by the agencies  

ECHA, 
EFSA,  
EMA 
EEA, 
EU-
OSHA   
COM  

Provision of data   

Providing ‘new scientific reference data’   ECHA, 
EFSA, 
EMA,  
EEA,  
EU-
OSHA  

Putting the data into the repository with adequate metadata 
information will require some additional resources from the 
agencies or from the rapporteurs of opinions. The amount will 
depend on how many opinions with limit values the agency sets 
per year. The work will be spread over time and could be absorbed 
by the resources spent on the development of the opinion, for 
example by ensuring that the opinion format has specific fields 
dedicated to the limit values information.   

Providing ‘legacy scientific reference 
values’   

ECHA, 
EFSA,   

EFSA has already compiled all ‘old scientific reference values’ in 
the open food tox repository; no additional resources needed for 
this;  

ECHA needs to progressively extract the old scientific reference 
values from their opinions. This would be a one-off exercise that 
could be outsourced. The following resources for contracting will 
be needed:  

ECHA:  
- 2026 (200 opinions): EUR 100 000  

165 

 
 
  
  
  
  
  
  
  
  
- 2027 (200 opinions): EUR 100 000  
- 2028: Euro 0 
The management of the contract is to be done as part of the 
common data platform resources  

Providing ‘formally adopted regulatory 
reference values’   

ECHA   ECHA has already a contractual agreement for the provision of 

reference values under the operation of EUCLEF. This should be 
expanded to cover all formally adopted regulatory reference 
values and to collate also necessary metadata.  

Receiving and processing national 
reference values   

The current EUCLEF financing related to data provision assumes 
the maintenance of 51 pieces of legislation, at a cost of EUR 8 
400/year for each legislation, or EUR 430 000/yearin total.  

To top-up EUCLEF to cover the Eur-Lex legislations with human 
health or environmental limit values in the scope of the repository, 
ca 25 pieces of legislation would be added to the current scope, 
amounting to an additional data provision cost of EUR 200 000 
/year. This is already covered in the estimation of the resource 
needs for operating and hosting the repository above. 

ECHA   A proposal for revision of water legislation requires MSs to report 
national EQS to ECHA. The resources for this part of the work 
were already proposed under the proposal for revision of water 
legislation (and are thus not covered under the proposal for a 
regulation establishing the common data platform).   

The only other national limit values of interest are the national 
occupational exposure limits (OELs). There is no legal obligation 
to report those to EU institutions. The same system/set up 
developed for water EQS could be used for the OELs and Member 
States would be asked to report voluntarily. No additional 
resources needed.   

Summary of additional resource needs for the establishment and operation of a repository of 
reference values: 

Agency 

Summary of tasks 

ECHA 

Designing and developing the repository as 
expansion of EUCLEF and as part of the 
common data platform 

Financial resource 
needs: 

Human resource 
needs: 

Operation/hosting, maintenance and update 
of the repository as part of the EUCLEF and 
of the common data platform 

Coordination of and consultation with other 
agencies contributing to the repository (as 
part of the common data platform) during 
development 

Providing ‘new scientific reference data’    

Providing ‘old scientific reference values’   

Providing ‘formally adopted regulatory 
reference values’ 

Receiving and processing national reference 
values 

2025: EUR 650 000 
2026: EUR 650 000 
2027: EUR 200 000 
2028: EUR 200 000 

2025: 1 TA, 0 CAs 
2026: 1 TA, 0 CAs 
2027: 1 TA, 0 CAs 
2028: 1 TA, 0 CAs 

166 

 
 
 
 
 
 
EFSA 

Contribution to the development phase    

Coordination of and consultation with other 
agencies contributing to the repository (as 
part of the common data platform) during 
development 

Providing ‘new scientific reference data’    

Providing ‘old scientific reference values’ 

EMA 

Contribution to the development phase    

Coordination of and consultation with other 
agencies contributing to the repository (as 
part of the common data platform on 
chemicals) during development 

Providing ‘new scientific reference data’ 
(i.e. PNECs)   

EEA 

Contribution to the development phase    

EU-
OSHA 

Coordination of and consultation with other 
agencies contributing to the repository (as 
part of the common data platform) during 
development 

Providing ‘new scientific reference data’ 

Financial resource 
needs: 

2025: EUR 0 
2026: EUR 0 
2027: EUR 0 
2028: EUR 0 

Human resource 
needs: 

Covered by EU common data 
platform on chemicals resource 
2025: 0 FTEs 
2026: 0 FTEs 
2027: 0 FTEs 
2028: 0 FTEs 

Financial resource 
needs: 

2025: EUR 0 
2026: EUR 0 
2027: EUR 0 
2028: EUR 0 

Human resource 
needs: 

Covered by EU common data 
platform on chemicals resource  
2025: 0 FTEs 
2026: 0 FTEs 
2027: 0 FTEs 
2028: 0 FTEs 

Financial resource 
needs: 

2025: EUR 0 
2026: EUR 0 
2027: EUR 0 
2028: EUR 0 

Human resource 
needs: 

No relevant data managed by 
the agencies;  
2025: 0 FTEs 
2026: 0 FTEs 
2027: 0 FTEs 
2028: 0 FTEs 

DG 
SANTE 

Contribution to the development phase    

Coordination of and consultation with other 
agencies contributing to the repository (as 
part of the common data platform on 
chemicals) during development 

Financial resource 
needs: 

2025: EUR 0 
2026: EUR 0 
2027: EUR 0 
2028: EUR 0 

Future budget line: DG Environment 

Candidate for fees: No 

23.  INFORMATION ON THE OBLIGATIONS UNDER UNION ACTS ON CHEMICALS  

Responsible body: 

Currently: Commission, delegated to ECHA 

(Re-)attribution planned to: ECHA 

Legal basis for (re-)attribution:  Proposal for a regulation of the European Parliament and of the 
Council establishing a common data platform on chemicals, laying down rules to ensure that the data 
contained in it are findable, accessible, interoperable and reusable and establishing a monitoring and 
outlook framework for chemicals 

167 

 
 
 
 
 
 
 
 
 
 
 
  
Type of task: existing 

Brief  task  overview:  Operation  of  a  database  with  information  on  the  provisions  and  legal 
obligations  applicable  to  chemicals  under  the  Union  acts  providing  a  single  point  of  entry  to 
information on various pieces of EU legislation applicable to a given chemical substance. 

Detailed process description 

Current process 

EU  Chemicals  Legislation  Finder  (EUCLEF)  is  a  database,  compiled  by  ECHA  from  multiple 
sources, presently covering 51 pieces of EU legislation and organized in a way that enables searching 
and  listing  all  regulations  and  regulatory  lists  in  which  a  substance  (directly,  or  inheriting  the 
regulatory context of a parent substance) appears. To ensure continuous relevance, the database is 
regularly  (several  times  per year) updated. Advanced searches, links to  applicable documents and 
exporting  of  aggregated  results  are  enabled.  Industry,  in  particular  SMEs,  is  the  principal  user 
addressed,  as  the  efficient  access  to  information  on  obligations  reduces  costs  and  increases 
compliance.   

EUCLEF is hosted by ECHA as part of its dissemination pages. EUCLEF has been developed and is 
maintained by an external contractor managed by ECHA. The information in the database is regularly 
updated also by the contractor who regularly searches for updates in legislative provisions, such as 
Eur-Lex, and keeps the EUCLEF database up to date.  

Changes envisioned as part of setting up common data platform 

Database with information on the provisions and legal obligations applicable to chemicals under the 
Union acts will be established as an integral dedicated service within the common data platform. The 
database  will  be  built  from  the  existing  EUCLEF.    Its  principle  task  should  not  change  from  the 
existing service, but the scope of EUCLEF will be slightly extended to cover all legislation within 
the scope of common data platform. In addition, EUCLEF will be reshaped to fit with the standard 
data format and controlled vocabulary and graphical interface to the common data platform. Further, 
EUCLEF  will  be  expanded  to  integrate  in  it  also  the  repository  of  reference  values,  as  it  partly 
overlaps in scope but also in sources and approaches required to keep the information updated.  

Proximity to ECHA mandate: ECHA has the appropriate data and expertise to perform this task. 
ECHA already operates the system in its current form and it fits well with the new mandate to operate 
the common data platform on chemicals.  

Projected synergies and added value of (re)attribution: 

Type 

Synergies 

Reuse of 
capabilities 

High 

ECHA’s existing processes and methodologies can be fully reused 
for the new task. Eventually the service will benefit from its 
position within the common data platform, exploiting capabilities 
developed within it. 

Re-use of data  High 

Reuse of data in the EU data space (Eur-Lex) and data collected 
under other chemicals legislation 

Low 

High 

Workload 
balancing 

IT tools: 
automation 
and economies 
of scale 

Existing process based on external contract. Integration 
requirements will be passed through revised specification.  

Reuse of existing solution, together with IT capabilities developed 
in the platform. Joint revision with the new repository of reference 
values. 

168 

 
 
Support 
services: 
economies of 
scale 

High 

Reuse of support services within the platform (e.g. substance 
identification, data management and dissemination). Reuse of 
administrative services. 

Type 

Added value 

Compliance, 
robust 
implementation 
leading to safe 
handling 

High 

Facilitating a comprehensive understanding of legal frames 
applying to a specific substance for its full lifecycle supports 
adequate and efficient activities, implementation of legislation 
and development of policies. 

Transparency 

High 

Compiling information that is public by default, but by merging 
and by using advanced tools to visualize the information provides 
a unique insight that is often missed by data alone.  

Main risks and opportunities:  

The  current  EUCLEF  solution  provided  by  an  external  consultant  is  robust  and  the  risks  of 
interrupting  the  continuous  provision  of  information  and  the  efforts  required  to  integrate  in  the 
platform  are  low,  provided  that  funding  is  maintained  at  a  similar  level  as  today.  There  is  an 
opportunity to allow for a more efficient update of the database by automating the reading of entries 
from  Eur-LEx.  For  that,  a  collaboration  with  the  Commission’s  publication  office  is  required  to 
ensure adequate structuring of the information in Eur-Lex. Another opportunity is to integrate the 
repository of reference values into the system, using joint efforts and practices.  

Projected impact on ECHA: 

•  ECHA committees/bodies: no impact. The task does not require the involvement of ECHA 

committees /bodies. 

•  ECHA data model and IT infrastructure: medium impact. Becoming a sustainable part of the 
common data platform, it will require some changes in the data model. However, being an 
existing service to be included in the platform, significant efforts in addition to continuous 
funding at the existing operational level should not be required. Given the investments in IT 
and data under the EUCLEF task since 2019, its continued implementation would not require 
significant further efforts in this area. 

-  ECHA key experts: low impact. The task relies on expert competencies, but as externally-
supported  service  in  the  operational  phase  this  requires  lower  ECHA  oversight,  and  the 
additional support to development the required for integration into the common data platform 
is expected to be covered by the ECHA experts dedicated to the platform development. 

Projected workload and resource implications:  

Current workload and resource use: 

ECHA already developed and currently maintains the EU Legislation Finder (EUCLEF). It does so 
under  a  Contribution  Agreement  with  DG  GROW  for  which  it  receives  a  varying  sum  of  money 
depending on the year (EUR 1 000 000 – EUR 1 400 000 annually), but no posts. ECHA runs the 
service through the employment of 4 interim staff members (ca. EUR 270 000/year) and outsourcing 
to  contractors:  communication  activities  and  external  helpdesk  ca.  EUR  60  000/year,  IT  costs  ca. 
EUR 200 000/year, data costs ca. EUR 430 000/year. Via the Contribution Agreement this activity 

169 

 
 
 
 
does  not  currently  contribute  to  the  cost  of  running  the  ECHA  (administrative  overhead  or  IT 
development). 

Future workload and resource needs: 

No additional resources are required for this work. The existing resources for EUCLEF will be used 
to continue operating, further developing and slightly expanding the system. The dedicated service 
on information  on the obligations under EU acts  on chemicals  will have  to  be integrated into the 
platform, but the resource needs for adaptation are already covered under the common data platform. 
The major extension of EUCLEF – incorporation of the repository of reference values – are accounted 
for separately (see section 22). Although no additional resources are required under the proposal for 
the regulation establishing a common data platform on chemicals and establishing a monitoring and 
outlook  framework  for  chemicals,  the  legislative  proposal  for  a  regulation  on  ECHA  that  is  in 
preparation should address the fact that the operation of the EUCLEF became a structural task for 
ECHA and that the financing should become part of the annual contribution to ECHA. 

Work description   

Who    Additional resource needs estimate  

Operation of dedicated service on 
information on obligations under EU acts 
on chemicals– maintaining the system, 
periodically updating the database with 
data 

 ECHA  None, but the existing resources and financing for EUCLEF must be 

maintained. 

Development phase - incorporation  of the 
dedicated service into the common data 
platform: reviewing, aligning database 
structure and format; association with 
controlled vocabularies (as they are being 
developed) 

ECHA   Resources required for the integration are already considered by the 
estimates on EUCLEF operation (above – some level of continuous 
adaptation to technical progress is part of operation) and under 
common data platform ECHA common data platform data ingestion 
estimation.  

Development phase – incorporation of 
repository of reference values into 
dedicated service on information on 
obligations under EU acts on chemicals 

ECHA  Resources estimated under the repository of health-based limit 

values.  

Summary of additional resource needs for the dedicated service on information on obligations under 
EU acts on chemicals: 

Agency 

Summary of tasks 

ECHA 

Operation of dedicated service on 
information on obligations under EU 
acts on chemicals – maintaining the 
system, periodically updating the 
database 

Financial resource needs: 

Human resource needs: 

2025: EUR 0 
2026: EUR 0 
2027: EUR 0 
2028: EUR 0 
2025: 0 FTEs 
2026: 0 FTEs 
2027: 0 FTEs 
2028: 0 FTEs 

Future budget line: n/a  

Candidate for fees: No 

24.  DATABASE ON ENVIRONMENTAL SUSTAINABILITY RELATED INFORMATION 

Responsible body:  

170 

 
 
 
 
 
 
 
Currently: N/A, no current process  

(Re-)attribution planned to: ECHA, EEA, EFSA, EMA and EU-OSHA  

Legal  basis  for  reattribution:    Proposal  for  a  regulation  of  the  European  Parliament  and  of  the 
Council establishing a common data platform on chemicals, laying down rules to ensure that the data 
contained in it are findable, accessible, interoperable and reusable and establishing a monitoring and 
outlook framework for chemicals 

Type of task: new (new infrastructure but building on existing datasets)  

Brief task overview: Setting up and operation of a database on environmental sustainability related 
data and providing relevant data to the database.   

Detailed process description:    

Current process:  

There  is  an  increasing  amount  of  data  related  to  environmental  sustainability  of  chemicals,  often 
generated  in  research  and  innovation  projects.  It  is  also  expected  that  the  implementation  of  the 
European  Green  Deal  and  its  various  initiatives,  including  the  implementation  of  the  Safety  and 
Sustainability by Design framework for chemicals and materials, as well as regulatory initiatives such 
as  the  Ecodesign  Regulation  for  sustainable  products  and  the  Sustainability  Corporate  Reporting 
Directive  will  further  increase  the  availability  of  certain  environmental  sustainability  data  for 
chemicals.  

There is no ongoing process to systematically collect all relevant information on the environmental 
performance  of  chemicals  throughout  their  lifecycle.  While  there  are  initiatives  compiling  (some) 
data used for sustainability assessments, in  particular data needed for the life cycle assessment  of 
products,  there  are  no  standard  data  formats  or  controlled  vocabularies  for  information  related  to 
environmental  sustainability,  which  hinders  coherence  between  assessments  of  the  impacts  of  the 
same chemical on the environment.  

Changes in the process:   

ECHA  is  to  set  up  and  operate  a  database  on  environmental  sustainability  related  data,  which  is 
established as part of the common pata Platform. For that purpose, ECHA extracts and feeds into the 
database information from all relevant datasets already integrated in the common data platform but 
also further relevant external datasets identified by the Commission.   

EEA,  EFSA,  EMA  and  EU-OSHA  provide  to  ECHA  relevant  data  related  to  environmental 
sustainability of chemicals they host or hold in addition to the chemicals data already available in the 
common data platform.   

Progressively, more data will be integrated in the database, as more data will become available in 
response  to  the  European  Green  Deal  and  the  various  initiatives  requiring  the  assessment  of 
sustainability of materials, products and services. Further datasets presently under preparation by the 
Partnership  for  the  Assessment  of  Risks  from  Chemicals  (PARC)  and  generated  through  the 
implementation of the safe and sustainable by design framework should be utilised and integrated as 
appropriate.  

The Commission identifies existing datasets on environmental sustainability related information for 
inclusion in the common data platform and designs relevant related database functionalities.  

The governance of the common data platform is used for governing the development and operation 
of the database.    

Proximity to agencies’ mandate:   

The task fits well with the mandate of each agency. ECHA has a long standing expertise on collection 
of information on substances. It is a key part of ECHA’s mandate. Other agencies (EFSA, EEA, EMA 

171 

 
 
and EU-OSHA) also collects or make available information on chemicals related to their mandate. 
EEA will in the future operate the Industrial Emissions Portal that might collect some data related to 
environmental sustainability of chemicals on industrial sites, including on 91 pollutants.   

Projected synergies and added value of (re-)attribution:   

Operating  only  one  database  to  systematically  collect  and  relate  all  relevant  information  on  the 
environmental performance of chemicals throughout their lifecycle and facilitate operation of tools 
and efficient assessment of environmental sustainability by different actors leads to synergies.   

Main risks and opportunities:   

There is a lot of activity in the field of sustainability assessments leading to multiple and not always 
coordinated activities and risks of ‘lock-in’ of specific solutions. A lot is still to be defined and agreed 
in  this  field;  even  some  of  the  concepts  are  still  under  development  and  testing.  Precise  advance 
planning of solutions is therefore not possible at present. The opportunity of having a central ‘beacon’ 
in  the  form  of  a  dedicated  database  around  which  the  activities  can  coalesce,  coordinate  and 
individually contribute is a major opportunity.  

Projected impact on agencies   

•  ECHA committees/bodies: no impact. There is no involvement of the committees  

•  ECHA data model and IT infrastructure: high impact. The task requires the development of 

an IT solution.    

•  EMA/EFSA/EEA/EU-OSHA data model and IT infrastructure: no or low impact.  agencies 

would provide the data they host or hold.  

Workload and resource implications:   

Current workload and resource use:  

This is a new task and there is no existing work or resources.  

Future workload and resource needs:   

The  additional  resources  are  needed  only  for  ECHA  for  the  development  of  the  database.  It  is 
envisaged that the majority of data to be integrated to the database will come from outside the EU 
agencies,  such  as  research  consortia  or  companies’  reporting.  The  EU  agencies  currently  do  not 
actively  collect  or  receive  the  relevant  data,  and  if  they  have  any  of  such  data,  the  amount  of 
information held is currently very limited. Therefore, the resources for provision of such data could 
be absorbed by the agencies.  

Work description    

Who    

Resource needs estimate   

Setting up the database on environmental 
sustainability related data 
Infrastructure setup  
Consultation on database functionalities   
Identification of relevant datasets already 
integrated in the common data platform  
Providing relevant input on environmental 
sustainability related information  

Operating the database on environmental 
sustainability related data 
Integrating additional datasets  

ECHA  

Development during 6 years (2025, 2026, 
2027,2028,2029, 2030);  
ECHA: Staff 1 FTE per year   

Negligible: to be absorbed by the agencies’ existing 
work.  

EEA, 
EFSA,   
EMA    
EU-OSHA 

ECHA  

Recurrent costs as of 2030:  
ECHA: Staff 1 FTE per year 

172 

 
 
   
   
  
   
   
  
Providing relevant environmental sustainability 
related information  

EEA, 
EFSA,   
EMA,    
EU-OSHA 

Negligible; should be absorbed by the agencies  

Summary of resource needs for the database on environmental sustainability related data: 

Agency 

Summary of tasks 

ECHA 

Database on environmental 
sustainability related data – developing, 
maintaining the system, periodically 
updating the database 

Financial resource needs: 

Human resource needs: 

2025: EUR 0 
2026: EUR 0 
2027: EUR 0 
2028: EUR 0 
2025:  1 TA, 0 CAs 
2026:  1 TA, 0 CAs 
2027:  1 TA, 0 CAs 
2028:  1 TA, 0 CAs  

Future budget line: DG ENV 

Candidate for fees: No 

25.  MECHANISM FOR INITIATING TESTING AND MONITORING 

Responsible body: 

Currently: EFSA, no current process exists beyond the food sector 

(Re-)attribution planned to: EFSA (as it is currently) and ECHA (for the new process for the chemical 
sector beyond chemicals covered by the General Food Law) 

Legal basis for reattribution:  Proposal for a regulation of the European Parliament and of the Council 
establishing  a  common  data  platform  on  chemicals,  laying  down  rules  to  ensure  that  the  data 
contained in it are findable, accessible, interoperable and reusable and establishing a monitoring and 
outlook framework for chemicals.  

Type of task: new 

Brief task overview: Commissioning scientific studies supporting the implementation and evaluation 
of legislation within the mandate of ECHA 

Detailed process description:  

Current process:  
Pursuant to the Transparency Regulation59, the Commission, in exceptional circumstances of serious 
controversies  or  conflicting  results,  may  request  EFSA  to  commission  scientific  studies  with  the 
objective of verifying evidence used in its risk assessment process. The studies commissioned may 
have a wider scope than the evidence subject to verification.  
At the same time, pursuant to Article 32 of the General Food Law60, EFSA, using the best independent 
scientific resources available, shall commission scientific studies necessary for the performance of its 

59 Regulation (EU) 2019/1381 of the European Parliament and of the Council of 20 June 2019 on the transparency and 
sustainability of the EU risk assessment in the food chain and amending Regulations (EC) No 178/2002, (EC) No 
1829/2003, (EC) No 1831/2003, (EC) No 2065/2003, (EC) No 1935/2004, (EC) No 1331/2008, (EC) No 1107/2009, 
(EU) 2015/2283 and Directive 2001/18/EC (OJ L 231 6.9.2019, p.1) 
60 Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the 
general principles and requirements of food law, establishing the European Food Safety Authority and laying down 
procedures in matters of food safety 

173 

 
 
  
 
 
 
 
 
mission. Such studies shall be commissioned in an open and transparent fashion and EFSA shall seek 
to  avoid  duplication  with  Member  State  or  Community  research  programmes  and  shall  foster 
cooperation through appropriate coordination. 

EFSA implements this latter obligation through regular commissioning of scientific studies managed 
by the Science Studies and Project  Identification and Development  Office (SPIDO). The goals  of 
these projects are: 

-  Enhance EFSA’s capacity to identify studies/projects benefitting regulatory processes/science 

-  Fill knowledge gaps to ensure preparedness for: 

o  Possible divergences on sensitive matters (‘verification’ studies) 

o  Future  risk  assessment  requirements  dues  to  evolving  scientific  knowledge  and 

legislation 

-  Enhance capacity building and build partnerships 

If  there  is  a  request  from  the  Commission  for  a  verification  study,  the  resources  are  used  for 
commissioning such study. No request has been received from the Commission so far.  

The EFSA roadmap for the studies for 2022 includes specific projects on artificial intelligence, new 
approach methodologies, environmental risk assessment, combined exposure to multiple chemicals. 
For the years 2023 and 2024 the roadmap includes studies on evidence-based risk communication in 
the  EU  food  safety  system,  OMICS  and  bioinformatic  approaches  in  risk  assessment,  new  risk 
assessment methodologies and harmonised animal welfare data and advancing aggregate exposure to 
chemicals in EU.  

New process:  

EFSA  will  continue  the  operation  of  their  mechanism  to  commission  scientific  studies,  which  is 
focused on food sector. 

ECHA will get a mandate to commission scientific studies for the performance of its mission, i.e. in 
support of the implementation or evaluation of chemicals legislation within the mandate of ECHA. 
The Commission will be empowered to request ECHA to commission such studies as well. 

ECHA  and  EFSA  will  have  to  closely  cooperate  when  commissioning  scientific  studies  to  avoid 
duplication, maximise synergies and ensure coherence of safety assessments across legislation in line 
with the one substance, one assessment objectives.  

Proximity to agencies’ mandate:  The task fits well with the mandate of ECHA because it is focused 
on the commissioning of studies which are in the mandate of ECHA.  

Projected synergies and added value of (re-)attribution:  

The added value of this task is that ECHA will be able to commission necessary studies and thus 
improve the implementation and evaluation of the legislation within its mandate and complement the 
existing  mechanism  for  the  chemicals  in  food  sector.  Synergies  will  be  achieved  by  requiring 
cooperation between EFSA and ECHA. In addition, ECHA will be able to create synergies with the 
work it is doing in support of PARC. 

Main risks and opportunities:  

The  main  opportunity  comes  from  joined  work  of  ECHA  and  EFSA  on  commissioning  studies, 
serving the plethora of chemicals legislation and thus improving the coherence and harmonisation of 
assessment methods across legislation.  

Projected impact on agencies : 

•  ECHA committees/bodies: low impact. The task does not require the involvement of ECHA 

174 

 
 
committees/bodies but ECHA may require input from the committees for the identification of 
study needs 

•  ECHA data model and IT infrastructure: no impact. This task does not have an impact on the 

IT infrastructure beyond storing the project outcomes 

-  ECHA key experts: medium impact. The task will rely on expert competencies, which are 

limited within ECHA and the agency may need to recruit additional personnel. 

Projected workload and resource implications: 

Current resources allocated to similar work: 

Resources allocated to EFSA for ‘food-related data generation mechanism’  

Human resources for additional ad hoc studies 

Toxicological studies (H2020-FP9) 

Additional operational budget for additional ad hoc studies (Prediction: 16 
studies a year) 

4 FTEs per year 

2 FTEs per year 

2020: EUR 6 million 
2021: EUR 10.5 million 
2022: EUR 15.0 million 
2023: EUR 15.0 million 
2024: EUR 15.0 million 

When the PARC project was initiated, 2 FTEs were allocated to ECHA to allow its engagement in 
the project and support its implementation.   

Future workload and resource needs: 

EFSA will continue operating its data generation mechanism. The additional work required for EFSA 
will be to cooperate with ECHA on commissioning studies and on joint decision-making on which 
studies to commission and how to perform them. These costs should be however absorbed by the 
existing resources.  

It  is  envisaged  that  there  will  be  synergies  between  the  studies  run  by  EFSA  and  by  ECHA,  for 
example from pooling study subjects of the projects into one commissioning. It is therefore expected 
that ECHA should get a lower amount of human and operational resources than EFSA. No additional 
resources would be needed to follow the research projects, as such resources were already allocated 
to ECHA for the PARC project.  

Summary of additional resource needs for a data generation mechanism: 

Agency 

Summary of tasks 

ECHA 

Commissioning scientific studies on its 
own initiative or on the request of the 
Commission 

Financial resource needs: 

EFSA 

Cooperating with EFSA on 
commissioning studies and on joint 
decision-making on which studies and 
how to follow-up 

Cooperating with EFSA on 
commissioning studies and on joint 
decision-making on which studies and 
how to follow-up 

Human resource needs: 

Financial resource needs: 

Human resource needs: 

Future budget line: DG Environment 

Candidate for fees: No 

2025: EUR 0 
2026: EUR 1 000 000 
2027: EUR 3 000 000 
2028: EUR 5 000 000 
2025:  1 TA, 0 CAs 
2026:  1 TA, 1 CAs 
2027:  1 TA, 1 CAs 
2028:  1 TA, 1 CAs 
Covered by the existing 
data generation 
mechanism 

Covered by the existing 
data generation 
mechanism 

175 

 
 
 
 
 
 
 
26.  MECHANISM FOR NOTIFICATION OF STUDIES 

Responsible body: 

Currently: EFSA 

(Re-)attribution  planned  to:  EFSA  (for  notifications  under  the  General  Food  Law61),  ECHA  (for 
notifications of  studies beyond the food sector) 

Legal  basis  for  reattribution:    Proposal  for  a  regulation  of  the  European  Parliament  and  of  the 
Council establishing a common data platform on chemicals, laying down rules to ensure that the data 
contained in it are findable, accessible, interoperable and reusable and establishing a monitoring and 
outlook framework for chemicals 

Type of task: new 

Brief  task  overview:  Operation  of  an  on-line  system  for  receiving  and  storing  notification  of 
information on studies commissioned or carried out cby industry and contractual research laboratories 

Detailed process description: 

Current process:  

To  ensure  that  the  EU  risk  assessor  has  knowledge  of  all  studies  performed  by  an  applicant, 
Regulation (EU) 2019/1381 (Transparency Regulation) contains a requirement to notify studies that 
are  commissioned  or  carried  out  in  the  context  of  the  preparation  of  an  application  for  approval 
process in the food chain, at pre-submission phase. Information about the notified studies is made 
public once a corresponding valid application has been submitted and information on it is made public 
in accordance with the applicable rules on transparency. The Transparency Regulation also provides 
for consequences and certain procedural requirements in the case of non-compliance. 

The studies are notified by the industry commissioning them as well as by the laboratories performing 
them. They are notified to EFSA and EFSA operates an online system (database) for receiving and 
storing the notifications. The system has existed for since 27 March 2021  and 15 652 notifications 
were received up until March 2023. 

EFSA verifies the compliance with the notification requirements once the application or notification 
is received in relation to which Union law contains provisions for EFSA to provide a scientific output.. 
This work is done automatically but requires also some manual checks.  

Future process: 

The  obligation  to  notify  studies  would  be  extended  from  the  food  legislation  to  all  chemicals 
legislation except the medicinal and veterinary products. EFSA would continue to operate its existing 
notifications database for notifications made under the General Food Law, while ECHA would set up 
its own database for notifications of studies carried out in the context of other EU chemical legislation.  

Verification of compliance with the notification requirement would be done by the actor or agency 
responsible for the legislation in question (e.g. under  Biocidal Products  Regulation, ECHA would 
verify the compliance with the notification of studies when application for authorisation for biocidal 
product or biocidal active substance would be received. Also, under REACH, ECHA would verify 
the compliance with the notification of studies as part of the compliance check of the registration 
dossiers). 

61 Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the 
general principles and requirements of food law, establishing the European Food Safety Authority and laying down 
procedures in matters of food safety (OJ L 31 1.2.2002, p.1) 

176 

 
 
 
Proximity to agencies’ mandate:  

The  task  is  very  close  to  the  EFSA  and  ECHA  mandate.  EFSA  already  operates  a  database  of 
notifications for the food sector. ECHA is or will be responsible for the assessment work under the 
remaining legislation (i.e. legislation beyond food sector), therefore, the operation of the notification 
database for the remaining legislation fits well with ECHA’s mandate.  

Projected synergies and added value of (re-)attribution:  

ECHA  can  build  on  EFSA’s  existing  expertise  and  experience  and  can  thus  ensure  harmonised 
identification of study notifications. Existing processes under the biocidal product regulation (such 
as  application  evaluation)  and  under  REACH  (such  as  dossier  compliance  check)  can  be  used  to 
include checking the compliance with the notification requirements.  

Projected impact on agencies: 

•  committees/bodies:  EFSA  -  no  impact.  The  task  does  not  require  involvement  of  EFSA 
committees /bodies. ECHA – low impact. The task would require checking compliance with 
the notification provisions by the rapporteur member of the biocidal product committee. 

•  Data  model  and  IT  infrastructure:  EFSA  -  low  impact.  The  existing  repository  of  studies 
continues  to  be  operated.  The  system  will  have  to  be  linked  with  or  incorporated  into  the 
common  data  platform.  ECHA  –  high  impact.  ECHA  will  need  to  set  up  a  new  IT 
infrastructure.  In  addition,  REACH  registration  will  have  to  be  adapted  to  facilitate  the 
reporting of the notification number for a submitted study.  

-  Key  experts:  ECHA  and  EFSA  -  low  impact.  The  task  will  rely  on  expert  competencies, 

which exist in the agencies.  

Projected workload and resource implications: 

Current workload and resource use: 

The following resources were allocated to EFSA for the implementation of the notification of studies 
mechanism as part of the transparency regulation: 

Resources allocated to EFSA for ‘food-related notification of studies’  

Register of commissioned studies 

2 FTEs per year 

Register of commissioned studies (development and operation) 

2020: EUR 160 000 
2021: EUR 280 000 
2022: EUR 400 0002023: EUR 
400 000 
2024: EUR 400 000 

Current budget line: DG SANTE  

Future workload and resource needs: 

ECHA will need to  set  up a database of study notifications and  an  IT interface for  receiving the 
notifications.  The  system  needs  to  be  operational  within  2  years  from  the  entry  into  force  of  the 
legislation  (expected  mid  2027).  ECHA  and  EFSA  will  have  to  cooperate  to  ensure  a  common 
approach for the identification of information notified to both systems. ECHA will have to build an 
automatic solution that requires lead registrants or applicant to include the notification number into 
the registration or biocidal product dossiers, respectively, or indicate the reason why a study was not 
notified.  It  will  also  require  adapting  the  dossier  format  to  capture  the  notification  number  or 
justification, and connect the submission system to the database of study notifications. This would be 
a one-off-cost of adapting the REACH IT and the biocidal products system. For setting up the system 

177 

 
 
 
it is estimated that additional 3 FTEs per year will be needed and an operational budget of EUR 1 600 
000 to commission the external support in the development of the system.   

Once  the  system  is  set  up  ECHA  will  have  to  operate  it,  maintain  it  and  make  the  necessary 
adaptations. ECHA will have to provide helpdesk to reply requests of duty holders. ECHA will also 
facilitate checking the compliance with the notification provisions.  

For  the  Biocidal  Products  Regulation,  the  notification  of  studies  would  be  checked  for  active 
substance approval as part of new applications, Art 95 dossiers and renewals. It can be estimated that 
there would be a need to check 50 dossiers a year (containing ca. 100 notifications). The notification 
of studies would be also checked for biocidal product authorisation. In 2022, 160 applications were 
received  (containing  ca.  45  notifications).  The  checks  would  be  performed  by  the  Member  States 
competent authorities, while ECHA would make available to them the summary of notifications. It is 
expected that verification of notifications would not take more than 4 hours per dossier. This could 
be  absorbed  by  the  overall  resources  dedicated  by  the  Member  States  for  the  evaluation  of  the 
applications,  as  it  is  marginal  compared  to  the  overall  resource  need  for  the  evaluation  of  an 
application. 

For  REACH,  ECHA  receives  from  lead  registrants  on  average  yearly  about  3  600  updates  of  the 
registrations and about 300 new registrations. Updates can be submitted for a variety of reasons and 
may or may not  contain studies. When submitted in  response to  an evaluation  decision and when 
submitted due to an increase in information requirements following an increased tonnage band, they 
most likely contain new studies. Companies may also include new studies for other reasons, e.g. to 
follow  regulatory  changes  or  to  strengthen  adaptations.  The  number  of  annually  submitted  new 
studies  from  increase  in  tonnage  band  and  in  response  to  evaluation  decisions  is  1  400.  The  new 
registrations are estimated to contain on average 12 studies, i.e. 3 600 studies for 300 new registrations 
per  year.  In  summary,  ECHA  receives  on  average  3  900  registrations  per  year  (updates  +  new 
registrations) containing some 5 000 experimental studies that would need to be notified per year. 
This would result in ca. 7 500 notifications, as it is assumed that ca. 50% of studies would have to be 
notified also by commercial laboratories.   

Compliance with the notification-of-studies requirement would be checked as part of the registration 
compliance check. ECHA checks approximately 300 registrations per year for compliance. Checking 
the compliance with the study-notification requirement would not take more than 4 hours per dossier. 
This would amount to 1 200 hour per year, i.e. ca 0.6 FTE. However, it is likely that registrations 
selected for a compliance check would not consist of only new registrations or updated registrations 
for  which  the  requirement  of  notification  of  studies  applies,  and  thus  the  number  of  checks  for 
complying with study-notifications requirements would be lower. In addition, when one is performing 
a full compliance check of a registration, the additional time for checking compliance with the study-
notification requirement is negligible. 

For any other legislation, ECHA might need to assist Member State authorities in their enforcement 
action and for those legislative pieces, where a dossier containing studies is submitted by duty holders 
to ECHA, ECHA can verify the compliance when evaluating such dossier (e.g. under RoHS directive, 
there might be some 3 dossiers per year requesting derogation which potentially might contain study 
results).  

It is estimated that 3 FTEs per year and an operational budget of EUR 200 000 per year will be needed 
for ECHA to operate the system, deal with requests from duty holders and to assist in compliance 
check.  

178 

 
 
ECHA will have to cooperate with EFSA also on the integration of EFSA’s notifications database 
into the common data platform. This part of work is covered by the resources planned for the common 
data platform. 

Summary of additional resource needs for the mechanism for notification of studies: 

Agency 

Summary of tasks 

ECHA 

Setup and operation of notifications database and ensuring 
common approach for the identification of information 
notified to EFSA and ECHA system  

Financial 
resource needs: 

Adaptation of the REACH registration system to include 
study notifications numbers 

Human resource 
needs: 

2025: EUR 0 
2026: EUR 1 200 000 
2027: EUR 400 000 
2028: EUR 200 000 
2025: 1 TA, 2 CA 
2026: 1 TA, 2 CA 
2027: 1 TA, 2 CA 
2028: 1 TA, 2 CA 

Adaptation of the biocidal products regulation system to 
include study notifications numbers 

Helpdesk 

Verification of compliance with the study notification 
requirements as part of the REACH compliance check and 
biocides authorization 

Support to Member State authorities in enforcement  

EFSA 

Continue running its existing notifications database   

Coordination with ECHA to ensure common approach for 
the identification of information notified to EFSA and 
ECHA systems 

Future budget line: DG Environment 

Candidate for fees: No 

Financial 
resource needs: 

Human resource 
needs: 

2025: EUR 0 
2026: EUR 0 
2027: EUR 0 
2028: EUR 0 

2025: 0 FTEs 
2026: 0 FTEs 
2027: 0 FTEs 
2028: 0 FTEs 

27.  EU  CHEMICAL  EARLY WARNING  AND  ACTION  SYSTEM  AND  INDICATOR  FRAMEWORK  FOR 

CHEMICALS  

Responsible body: 

Currently: EEA, ECHA  

(Re-)attribution planned to: EEA, ECHA in collaboration with EFSA, EMA and EU-OSHA 
(expanding the task) 

Legal  basis  for  reattribution:    Proposal  for  a  regulation  of  the  European  Parliament  and  of  the 
Council establishing a common data platform on chemicals, laying down rules to ensure that the data 
contained in it are findable, accessible, interoperable and reusable and establishing a monitoring and 
outlook framework for chemicals 

Type of task: existing (Task 2) and new (Task 1) 

Brief task overview:  

1.  Establishment and operation of an EU early warning and action system for emerging chemical 
risks through developing and compiling early warning signals and drawing up summary report 
to inform regulatory follow up actions 

179 

 
 
 
 
 
 
 
 
2.  Establishment and operation of the indicator framework for chemicals 

Detailed process description:   

Current process: 

Task 1 is a new task and there is no ongoing process or activity for this task.  

As regards Task 2 (framework of indicators), the EEA and ECHA are jointly developing a framework 
of indicators for chemicals policy to monitor the drivers and impacts of exposure of environment and 
humans to chemicals and to provide a fact base to measure the effectiveness of chemicals legislation 
in protecting human health and the environment. The framework of indicators is being developed as 
part  of  the  framework  of  indicators  for  zero  pollution.  The  indicators  for  chemical  policies  are 
expected to monitor:  

• 

• 

the drivers of human and environmental exposure to chemicals, namely the production and 
use of chemicals, regulation of these activities;   

the impacts of chemicals, in terms of emissions and occurrence in environmental matrices and 
in  humans  compared  against  effect  levels,  and—where  possible—their  impacts  on  human 
health and the environment; 

•  progress with the industrial transition to safe and sustainable chemicals. 

The framework will consist of a set of indicators that is annually updated and presented in the form 
of a dashboard. EEA and ECHA plan to publish the baseline information for the first set of indicators 
in 2024. The EEA and ECHA are the technical co-leads of the Commission inter-service working 
group on chemicals indicators (WG8 of the Chemicals Strategy). During 2021, the working group 
developed  the  first  concept  paper  and  agreed  on  the  full  set  of  candidate  indicators.  In  2022  the 
indicators  were  further  developed,  in  cooperation  with  the  services  involved.  For  each  candidate 
indicator,  EEA  and  ECHA  prepared  a  prototype  and  validated  data  availability,  potential  data 
representation and interpretation. In 2023 EEA and ECHA will prepare the dashboard, conclude the 
development  of  the  indicators  and  case  studies,  as  well  as  develop  the  synthesis  report.  EEA  and 
ECHA have established a data flow to quantify the selected indicators, and will continue to coordinate 
work for the preparation of indicators that are expected to be available after 2024.   

Changes in the process / New process: 

Task 1 – early warning and action system 

This is a new task. The early warning and action system will complement the implementation of the 
EU legislation on chemicals by adopting a proactive and systematic approach to the identification of 
emerging chemical risks. The system will consist of an annual compilation of a report summarising 
the  collection  of  early  warning  signals,  identifying  potential  emerging  risks  from  chemicals  and 
presenting the report and its finding to the expert working group on one substance, one assessment 
for discussion and decision on the need for potential follow-up policy or regulatory action. The system 
would be developed progressively. Initially, it will rely on existing early warning systems and signals, 
such as the EFSA’s emerging risks exchange network (EREN), the national warning systems (e.g. 
SamTox, SIGNAAL), targeted literature searches performed by EEA, as well as on relevant existing 
data and information made available by EFSA, ECHA, EEA, EMA and EU-OSHA. Progressively, 
more signals would be developed by the cooperating agencies (i.e. EEA, ECHA, EFSA, EMA, EU-
OSHA) and the tools for early warning signals developed by the Partnership for the Assessment of 
Risks from Chemicals (PARC) would be utilised and integrated as appropriate.  

The  types  of  signals  that  could  feed  into  the  EU  early  warning  and  action  system  for  emerging 
chemical risks include:  

• 

substances on the market currently produced and used in small quantities but with high growth 
potential, 

180 

 
 
•  new substances at research and development stage not yet on the market, 
•  new scientific knowledge leading to a more critical assessment of the risk (e.g., discovery of 

subtle effects or sensitive species), 

•  New substances on the market, such as recently developed substitutes for regulated 

• 

substances, 
substances for which emerging evidence raises concerns due to:  
➢  improvements in the sensitivity of analytical methods,  
➢  chemical mixtures/combination effects of chemicals, 
➢  new toxicological evidence, 
➢  newly identified exposure routes, 
➢  increasing levels and scale of exposure or trends in the profile of the exposure, 
➢  development of the legislation, 
➢  new susceptible at-risk population or at-risk groups.  

industry data (e.g., development of alternatives, production volumes) 

• 
•  biological signals (e.g., biodiversity loss)  

Task 2 

This is an existing task. The framework of indicators will be maintained and further developed by 
EEA in collaboration with ECHA, EFSA, EMA, EU-OSHA and the Commission. The dashboard of 
indicators  shall  be  integrated  into  the  common  data  platform  on  chemicals  and  the  relevant 
information shall be made available as part of the report on early warnings.  

Proximity to Agencies’ mandate:  

The task of having a lead for the early warning system for chemicals fits well with the core mandate 
of EEA, as EEA already operates a number of early warning systems for other areas (e.g. waste). The 
task of co-developing the indicator framework fits well with the mandates of EEA and ECHA, as 
ECHA is  an  agency that as part of the operation of common data platform  manages  access  to  all 
chemicals related data held by other agencies  and EEA already operates number of indicators as part 
of its work on the assessment of the state of environment. The task of providing information/data for 
the  early  warning  system  and  indicator  framework  within  their  competence  fits  well  with  the 
mandates  of  EEA,  ECHA,  EFSA,  EMA  and  EU-OSHA  as  they  collate  and  hold  the  relevant 
information as part of their mandates.  

Projected synergies and added value of (re-)attribution:  

Attribution of the lead to EEA will provide for synergies with existing early warning systems and 
with the EEA’s work on indicators, including its work on the zero-pollution indicator framework. 
EEA has already been tasked to develop a framework of indicators in collaboration with ECHA. For 
EEA, the lead on an early warning system can be considered as a natural expansion of its work on 
indicators, as several indicators can serve also as early warning signals. In addition, EEA (and also 
ECHA) are involved in the Partnership for the Assessment of Risks from Chemicals (PARC) through 
which they can steer the development of the tools for early warning signals.   

Projected impact on agencies: 

-  EEA/ECHA/EMA/EFSA/EU-OSHA committees/bodies: low impact. EEA might use some 
of their networks for the provision of early warning signals. No other additional impact on 
committees is expected for EMA, EFSA, ECHA or EU-OSHA 

-  EEA  data  model  and  IT  infrastructure:  low  impact.  The  task  can  be  implemented  with 

adjustments / configuration of existing data structures and IT systems. 

-  EEA/ECHA/EMA/EFSA/EU-OSHA  key  experts:  low  impact.  Expertise  existing  in  the 

agencies can be used for these tasks.  

Workload and resource implications:  

181 

 
 
Current workload and resource use: 

Task 1 is a new task and there is no existing work or resources.  

Task 2 is an existing task. Resources for this work were allocated to both EEA and ECHA, as part of 
the resource allocation under the 8th Environment Action Programme. ECHA uses 2 FTEs (1 TA and 
1 CA) for the development of the chemical indicators (out of 2 FTEs allocated under the 8th EAP). 
These resources are used by ECHA for the management and consolidation of databases, provision of 
chemicals data in order to complete the respective emerging risk reports and contribution to chemical 
policy indicators and other inputs to EEA’s work. EEA uses 1 FTE for the work on indicators (out of 
15  allocated  under  the  8th  EAP).  These  resources  are  used  by  EEA  for  the  integrated  analysis  of 
pollution  impacts  on  environment  and  health  and  on  reporting  on  cross-cutting  areas  of  the  zero-
pollution ambition of the green deal, in close cooperation with ECHA and EFSA. 

Future workload and resource needs:  

Task 1 – Early warning and action system for emerging chemicals risks 

Work description   

Who   

Resource needs estimate  

Setting up the EU early warning and action system 

Identifying and selecting existing working procedures, 
setting up the necessary contacts with other agencies and 
Member  States  experts,  developing  the  early  warning 
signals available in EEA. 

EEA 

Compiling  report  on  system  set-up,  signal  generators 
and data sources, working procedures and consulting the 
expert  group  on  one  substance,  one  assessment  for 
feedback 

Providing  relevant  input  for  the  setting  up  the  early 
warning and action system 

ECHA, 
EFSA,  
EMA  , 
EU-OSHA 

Operating the EU early warning and action system 

Development by 2026; development 
duration 2 years (2025, 2026); Resource 
needs: 
- 
-  Operational budget EUR 300 000 in 

Staff 1 FTE per year 

2026 

Setting up of the system and compiling 
report shall be based on information 
gathered from identified signal generators, 
including ECHA, EFSA, EU-OSHA and 
EMA.  

Negligible: to be absorbed by the agencies’ 
existing work. 

182 

 
 
  
  
 
  
  
Conduct a horizon scanning and foresight exercise, 
including organising an annual workshop, to identify 
early warning signals, including:  

• 
• 

• 

• 

• 

performing a literature search,  
reviewing the EEA data flows on chemicals in 
the environment 
compiling the early warning signals from 
collaborating EU agencies, including from 
data provided by ECHA, EFSA and EMA and 
EU-OSHA 
compiling the early warning signals from 
relevant initiatives, such as the EEA Eionet 
network and Horizon Europe partnership 
PARC 
operating relevant early warning tools 
developed under PARC. 

Producing and publishing an annual report on early 
warning signals and presenting it to Commission, 
relevant EU agencies and Member States for decision 
on potential regulatory follow up actions.  

Providing relevant data and information on early 
warning risks 

EEA 

Recurrent costs as of 2027: 

Staff 1 FTE per year  

- 
-  EUR 150 000 per year for annual 

studies for literature review, horizon 
scanning, foresight and support in 
systemic examination of potential 
chemical risks and covering annual 
workshop costs 

Operating the system and compiling report 
shall be based on information gathered from 
identified signal generators, including 
ECHA, EFSA and EMA.  

ECHA, 
EFSA,  
EU-OSHA 
EMA,   

Negligible; should be absorbed by the 
agencies; EFSA already operates food 
related early warning system; ECHA 
develops indicators and the resources 
allocated for that should cover also this 
activity; EMA and EU-OSHA should 
contribute with the existing information they 
identify. 

Task 2 – Framework of indicators 

There is no need for additional resources for Task 2, but the current resources need to be maintained 
to ensure operation of the indicator framework.  

Work description   

Who   

Resource needs estimate  

Maintaining and further developing the 
framework of indicators for chemicals  

EEA, 
ECHA 

Resources already allocated (EEA: 1 FTEs, ECHA: 
2 FTEs) No additional resources needed, but they 
should be maintained 

Summary of additional resource needs for early warning and action system and indicator framework 
for chemicals:  

Agency 

Summary of tasks 

EEA 

Literature review, horizon scanning, foresight and 
support in systemic examination of potential 
chemical risks and covering annual workshop costs  

Financial 
resource 
needs: 

Review  of  existing  working  procedures  for  early 
warning  signals  for  chemicals,  including  signal 
generators. 

Human 
resource 
needs: 

Review of EEA data flows on chemicals in the 
environment to identify early warning signals 
available in EEA. 

2025: EUR 0 
2026: EUR 300 000 
2027: EUR 150 000 
2028: EUR 150 000 
2025: 1 TA, 0 CAs 
2026: 1 TA, 0 CAs 
2027: 1 TA, 0 CAs 
2028: 1 TA, 0 CAs 

183 

 
 
 
 
 
 
 
 
 
 
 
 
Compiling the early warning signals from 
collaborating EU agencies. 

Compiling the early warning signals from relevant 
initiatives, such as the EEA Eionet network and 
Horizon Europe partnership PARC, including with 
the early warning tools developed under PARC, as 
appropriate. 

Producing and publishing an annual report on early 
warning signals and presenting it to expert group on 
one substance, one assessment. 

Providing relevant data and information on early 
warning risks within their competence. 

ECHA 

EMA 

EFSA 

EU-OSHA 

Budget line: DG Environment  

Candidate for fees: No 

Financial 
resource 
needs: 

Human 
resource 
needs: 

None, it should be 
absorbed by the agency 

None, it should be 
absorbed by the agency 

28.  OBSERVATORY  FOR  SPECIFIC  CHEMICALS  WITH  POTENTIAL  CONTRIBUTION  TO  EMERGING 

CHEMICAL RISKS  

Responsible body: 

Currently: Commission, delegated to ECHA 

(Re-)attribution planned to: ECHA 

Legal  basis  for  reattribution:    Proposal  for  a  regulation  of  the  European  Parliament  and  of  the 
Council establishing a common data platform on chemicals, laying down rules to ensure that the data 
contained in it are findable, accessible, interoperable and reusable and establishing a monitoring and 
outlook framework for chemicals 

Type of task: existing 

Brief task overview: Operate the observatory for specific chemicals with potential contribution to 
emerging chemical risks 

Detailed process description: 

Current process:  

ECHA operates EU Observatory for nanomaterials (EUON) that includes the following activities:  

•  Dissemination and communication (webpages, newsletters, opinions) about different aspects 

of nanomaterials;  

•  Commissioning number of ‘paper’ studies every year on various aspects of nanomaterials to 
fill knowledge gaps based on the proposals received from stakeholders via an open call for 
proposals; 

•  Running  the  NanoData  nanotechnology  knowledge  base  which  periodically  takes  stock  of 
market development on nanomaterials (e.g. statistics of growth in sectors, patents, ….); 
•  Providing  service  as  a  portal  to  ‘nano’  community  where  links  to  external  resources  (e.g., 
eNanoMapper serving as a common resource where EU-funded projects on nanomaterials and 
nanotechnologies can place their results and where some tools are made available); 

•  Operating a database that compiles data on nanomaterials from some sources, such as REACH 

184 

 
 
 
registration, EU nano inventories (FR, BE) - and present it together with a slightly advanced 
search functionality linked to nanoforms.  

The EUON is funded by the European Commission and is hosted and maintained by ECHA. 

Changes in the process:  

Continue  performing  ‘the  EUON’  activities,  maintaining  the  principal  objective  of  providing 
transparency on selected class of materials, but modifying its remit and exploiting new infrastructure: 

-  Expanding the scope to other chemicals and materials, such as complex advanced materials 
or  (other)  materials  identified  through  the  early  warning  system,  selected  based  on    the 
assessment  by  the  Commission  of  expected  need  and  benefit  of  their  inclusion  in  the 
observatory;  

-  Using as appropriate the new data generation mechanism to commission also studies related 
to nanomaterials (initially) and, later, also other selected groups of chemicals and materials; 
-  Operating a database that compiles data on nanomaterials and making it accessible via the 
common data platform to maximize integration with information from other datasets in the 
platform and its utility as additional source of information, including as appropriate in work 
on the framework of indicators; 

-  ECHA to dedicate part of its dissemination  effort on chemicals to nanomaterials (initially) 

and other materials(later). 

Proximity to agency mandate: the EUON task was assigned to ECHA because it was assessed to 
have the appropriate data and expertise to perform this task, this is confirmed by the fact that  this 
task has been successfully  performed by ECHA for over more than 5 years.  

Main risks and opportunities: There are clear synergies and overlaps between EUON’s compilation 
of  European  nanomaterial  inventories  (“Search  for  nanomaterials”  section)  and  the  future  EU 
common  data  platform  on  chemicals.  There  are  also  clear  synergies  and  overlaps  between 
commissioning studies on nanomaterials and the new data generation mechanism. There might be 
also some overlaps and synergies between the NanoData nanotechnology knowledge base and the 
work  on  the  famework  of  indicators  and  on  the  early  warning  system.  The  exploitation  of  these 
overlaps is an opportunity of the reattribution of tasks proposal. 

Projected impact on ECHA: 

•  ECHA committees/bodies: no impact. The task does not require the involvement of ECHA 

committees /bodies. 

•  ECHA data model and IT infrastructure: low impact. Given the investments in IT and data 
under this task since 2017, its continued implementation would not require significant 
further efforts in this area. The existing databases can be integrated into the common data 
platform. 

•  ECHA key experts: high impact. The task heavily relies on expert competencies, which are 

limited within ECHA and also critical to REACH/CLP/BPR regulatory tasks. 

Projected workload and resource implications:  

Current workload and resources used:  

The work is financed via the Contribution Agreement between ECHA and DG GROW and sometimes 
additional funding from DG RTD. The contribution consists of approximately EUR 700 000 per year 
(calculated as an average of contributions over the last 10 years: 2016 - EUR 900 000, 2017 – EUR 
600 000, 2018 – EUR 600 000, 2019 – EUR 600 000, 2020 – EUR 828 000, 2021 – EUR 600 000, 
2022 – EUR 809 000, 2023 – EUR 614 000, 2024 – EUR 619 000, 2025 – EUR 624 000). From the 
contributions received, ECHA employs 3 CAs (ca. EUR 270 000) and uses ca. EUR 430 000 as an 
operational budget for commissioning or the calls.  

185 

 
 
The current resources spent by the Commission can be summarized as follows: 

DG GROW – ECHA contribution agreement  

3 FTEs (3 CAs) 

Operational budget 

EUR 430 000 per year  

Current budget line: DG GROW (SMP-COSME) 

Future workload and resource needs: 

Keeping it as a coherent set of services compiling and disseminating reliable information on selected 
groups of  materials, the Commission intends to integrate the work of the EUON into other work 
streams assigned to the agency, namely operating the nanomaterials database as part of the common 
data platform, commissioning certain studies through the new data generation mechanism, integrating 
some signals from the NanoData nanotechnology knowledge base into the work onthe framework of 
indicators  and  an  early  warning  and  action  system,  and  specific  dissemination  into  general 
communication  on  chemicals.  The  scope  of  EUON  will  be  also  extended  to  other  chemicals  and 
materials,  such  as  complex  advanced  materials  or  (other)  materials  identified  through  the  early 
warning system, selected based on the assessment by the Commission of expected need and benefit 
of their inclusion in the observatory 

No  additional  resources  are  required  for  this  work,  but  the  existing  resources  for  EUON  must  be 
maintained.  The existing resources for EUON will be used to continue operating, further developing 
and slightly expanding the system. The dedicated service on information on the obligations under EU 
acts on chemicals will have to be integrated into the platform, but the resource needs for adaptation 
are already covered under the common data platform. Although no additional resources are required 
under  the  proposal  for  the  regulation  establishing  a  common  data  platform  on  chemicals  and 
establishing  a  monitoring  and  outlook  framework  for  chemicals,  the  legislative  proposal  for  a 
regulation on ECHA that is in preparation should address the fact that the operation of the  EUON 
became  a  structural  task  for  ECHA  and  that  the  financing  should  become  part  of  the  annual 
contribution to ECHA. 

Summary  of  additional  resource  needs  for  the  observatory  for  specific  chemicals  with  potential 
contribution to emerging chemical risks:  

Agency 

Summary of tasks 

ECHA 

Commissioning of studies on nanomaterials 
and other materials potentially presenting 
new emerging chemical risks (e.g., complex 
advanced materials via the data generation 
mechanism 

Operating ‘nanomaterials’ database 

Dissemination and communication on nano- 
and (e.g., complex advanced) materials  

Running the NanoData nanotechnology 
knowledge database. Providing service to 
‘nano’ community 

Financial resource 
needs: 

2025: EUR 0 
2026: EUR 0  
2027: EUR 0 
2028: EUR 0 

Human resource needs:  2025:  0 FTEs 
2026:  0 FTEs 
2027:  0 FTEs 
2028:  0 FTEs 

Budget line: n/a 

Candidate for fees: No 

186 

 
 
 
 
 
 
 
 
 
29.  COOPERATION OF ECHA WITH OTHER EU AGENCIES 

Responsible body: 

Currently: ECHA 

(Re-)attribution planned to: ECHA, expanding the existing tasks 

Legal basis for reattribution: ECHA founding regulation 

Type of task: New, expanding the existing task  

Brief task overview:  

1.  Developing methodologies for assessment of chemicals in the fields falling within its 

mission; 

2.  Cooperating  with  other  agencies  as  regards  exchange  of  data,  defining  formats  and 
controlled vocabularies and development of methodologies related to chemicals;  

3.  Preventing and solving divergent opinions on chemicals with EFSA and EMA. 

Detailed process description: 

Current process: 

Task 1 

ECHA has some very specific tasks with some relevance to the development of methodologies 
mentioned in the current founding provisions under REACH. The Article 77 of REACH on the 
tasks of the Agency lists the following tasks:  

•  providing  technical  and  scientific  guidance  and  tools  where  appropriate  for  the 
operation of this Regulation in particular to assist the development of chemical safety 
reports (in accordance with Article 14, Article 31(1) and Article 37(4)) and application 
of  Article  10(a)(viii),  Article  11(3)  and  Article  19(2)  by  industry  and  especially  by 
SMEs;  and  technical  and  scientific  guidance  for  the  application  of  Article  7  by 
producers and importers of articles; 

•  providing  technical  and  scientific  guidance  on  the  operation  of  this  Regulation  for 
Member State competent authorities and providing support to the helpdesks established 
by Member States under Title XIII; 

•  providing advice and assistance to manufacturers and importers registering a substance 

in accordance with Article 12(1); 

•  preparing explanatory information on this Regulation for other stakeholders; 
•  keeping a Manual of Decisions and Opinions based on conclusions from the Member 
State Committee regarding interpretation and implementation of this Regulation; 

ECHA however lacks the mandate and obligation to develop methodologies for the assessment 
related to chemicals. This disadvantages the ECHA as compared to other agencies and does 
not  allow  ECHA  to  actively  participate  or  contribute  to  the  development  of  assessment 
methods.  

Task 2 

The ECHA founding provisions under REACH contain provisions related to cooperation. The 
Article 110 of REACH on the relations with relevant community bodies states:  

•  The Agency shall cooperate with other Community bodies to ensure mutual support in 
the accomplishment of their respective tasks in particular to avoid duplication of work.  

187 

 
 
•  The Executive Director, having consulted the Committee on Risk Assessment and the 
European  Food  Safety  Authority,  shall  establish  rules  of  procedure  concerning 
substances for which an opinion has been sought in a food safety context. These rules 
of  procedure  shall  be  adopted  by  the  Management  Board,  in  agreement  with  the 
Commission.  This  Title  shall  not  otherwise  affect  the  competences  vested  in  the 
European Food Safety Authority.  

•  This Title shall not affect the competences vested in the European Medicines Agency. 
•  The  Executive  Director,  having  consulted  the  Committee  on  Risk  Assessment,  the 
Committee  on  Socio-economic  Analysis  and  the  Advisory  Committee  on  Safety, 
Hygiene and Health Protection at Work, shall establish rules of procedure concerning 
worker protection issues. These rules of procedure shall be adopted by the Management 
Board, in agreement with the Commission.  
This Title shall not affect the competences vested in the Advisory Committee on Safety, 
Hygiene and Health Protection at Work and the European Agency for Health and Safety 
at Work. 

The  existing  provisions  are  rather  general.  In  order  to  achieve  the  one  substance,  one 
assessment ambition, it is necessary to strengthen the provisions on cooperation and make them 
coherent with the provisions of other EU Agencies. 

Task 3 

ECHA founding regulation specifies provisions for preventing and solving divergent scientific 
opinions with other agencies. Article 95 on conflicts of opinion with other bodies states: 

•  The Agency shall take care to ensure early identification of potential sources of conflict 
between  its  opinions  and  those  of  community  law,  including  Community  Agencies, 
carrying out a similar task in relation to issues of common concern.  

•  Where  the  Agency  identifies  a  potential  source  of  conflict,  it  shall  contact  the  body 
concerned  in  order  to  ensure  that  any  relevant  scientific  or  technical  information  is 
shared  and  to  identify  the  scientific  or  technical  points  which  are  potentially 
contentious.  

•  Where there is a fundamental conflict over scientific or technical points and the body 
concerned is a Community Agency or a scientific committee, the Agency and the body 
concerned shall work together either to solve the conflict or to submit a joint document 
to the Commission clarifying the scientific and/or technical points of conflict. 

The provisions need to be aligned with those for other agencies. In addition, there is a need to 
strengthen the requirement to solve the divergent view by agencies among themselves, before 
the matter is referred to the Commission to be solved.  

Future process: 

Task 1: 

ECHA  should  have  a  mandate  to  develop  methodologies  for  the  assessments  related  to 
chemicals it performs based on its needs. It should have also a mandate similar to EFSA to 
promote  and  coordinate  the  development  of  uniform  risk  assessment  methodologies  in  the 
fields falling within its mission.  

Task 2: 

ECHA actively cooperates with EFSA, EEA and EMA as regards: 

- 

exchange of data on chemicals and defining formats and controlled vocabularies for 

188 

 
 
such data 

-  development of methodologies related to chemicals.  

The cooperation is foreseen both  ways,  i.e. when ECHA itself makes some development in 
those specified areas  within its domain as well as  when EFSA, EEA and EMA make some 
development in those areas within their domains. The goal is to ensure coherence, consistency 
and interoperability in the specified areas.  

Task 3: 

ECHA and body concerned shall first attempt to solve the divergent opinion on scientific or 
technical issues by themselves. They shall revert the decision to the Commission only if they 
were not able to solve the issue. In addition, if the divergence come from divergence in hazard 
assessment,  the  Commission  should  request  ECHA  to  prepare  a  proposal  for  harmonised 
classification under the CLP regulation. 

Proximity to Agency mandate: The tasks fit well with the mandate of ECHA as all three tasks 
target  the  areas  of  the  ECHA  mandate,  and  they  are  just  improvement,  specification  or 
expansion of existing tasks. 

Projected synergies and added value of  reattribution:  Improving  coherence,  consistency 
and interoperability among the Agencies work is the key added value.  

Projected impact on ECHA: 

•  ECHA  Committees/bodies:  low  impact.  The  task  might  require  some  ad  hoc 

involvement of committee/panels or their consultation.  

•  ECHA data model  and  IT infrastructure:  low impact. The task  can be implemented 

with adjustments / configuration of existing data structures and IT systems 

•  ECHA key experts: low impact. The task relies on expert competencies, but the task is 

limited and spread over time in its nature.  

Workload and resource implications: 

Future workload and resource needs: 

The work on the new tasks is limited and spread over time in it is nature. On a need basis, it 
requires  that  ECHA  will  develop  methodologies  for  the  assessment  it  performs  as  regards 
chemicals. The development and setting the methodology is a standard practice for whoever 
performs the assessments, so this task can be seen as a formalisation of existing ECHA work. 
There is no need for additional resources for this task. 

ECHA will need to cooperate with EFSA, EEA and EMA in the areas on data, formats and 
methodologies. The need for additional resources for cooperation on these are already covered 
under the legislative proposal on data (operation of common data platform) or they are already 
within the mandate of ECHA. Consequently, there is no need for additional resources on this 
general formal mandate for ECHA to cooperate. 

ECHA will need to try to solve any divergence in technical or scientific issue with the other 
agency. ECHA already has such obligation in the existing regulation. The new task will require 
that  the  agencies  make  more  effort  to  solve  the  issue  among  themselves,  instead  of  just 
forwarding the problem to the Commission. Although it might require slightly higher amount 
of work by the agency as compared to today, such situations are rare and therefore this can be 
absorbed by the agency without any additional resources.  

189 

 
 
Summary of additional resource needs for cooperation of ECHA with other EU Agencies: 

Agency 

Summary of tasks 

ECHA 

- Development of methodologies for 
assessments related to chemicals within its 
missions 
- Cooperation with EFSA, EEA and EMA on 
issues related to chemicals 
- Preventing and solving divergent opinions or 
assessments  

Financial resource 
needs: 

Human resource 
needs: 

2024: EUR 0  
2025: EUR 0 
2026: EUR 0 
2027: EUR 0 
2028: EUR 0 
2024:  0 FTE 
2025:  0 FTE 
2026:  0 FTE 
2027:  0 FTE 
2028:  0 FTE 

Future budget line: DG GROW  

Candidate for fees: No 

30.  SCIENTIFIC OPINIONS ON OCCUPATIONAL EXPOSURE LIMITS 

Responsible body: 

Currently: Commission, delegated to ECHA 

(Re-)attribution planned to: ECHA 

Legal basis for reattribution: ECHA founding regulation 

Type of task: existing 

Brief task overview: Assessments underpinning setting the EU occupational exposure levels 

Detailed process description: 

Current process: 

Occupational exposure limit (OEL) values are adopted under two legal frameworks (Chemical 
Agents  Directive  (CAD)  and  Carcinogens  and  Mutagens  Directive  (CMD))  that  form  an 
integral part of the EU’s mechanism for protecting the health of workers. In addition, there is 
a specific directive on asbestos that includes an OEL for this substance. Occupational exposure 
limits adopted by the EU need to be integrated into the national legislative framework. 

ECHA  and  its  Committee  for  Risk  Assessment  (RAC)  have  been  supporting  the  European 
Commission’s Directorate-General for Employment, Social Affairs and Inclusion (DG EMPL) 
by providing scientific opinions on OELs since 2019. This work was previously carried out by 
DG EMPL’s Scientific Committee on Occupational Exposure Limits (SCOEL). 

Following the request from DG EMPL, ECHA prepares a scientific report for its Committee 
for Risk Assessment (RAC) based on the available scientific data and any relevant information 
collected through a 90-day call for evidence. The scientific report is subject to a 60-day open 
consultation. RAC then develops its opinion based on a review of ECHA’s scientific report and 
the information provided during the consultation. ECHA’s scientific report becomes an integral 
part of RAC’s opinion and forms an annex to the opinion. The adopted final RAC opinion is 
then forwarded to DG EMPL. 

DG  EMPL  will  discuss  RAC’s  report  in  the  tripartite  Working  Party  on  Chemicals.  This 
working party prepares a draft opinion on the proposed occupational exposure limit, which is 

190 

 
 
 
 
 
then presented to the tripartite Advisory Committee on Safety and Health for adoption. In the 
end, the Commission adopts a legislative proposal. For binding OELs, this happens through 
the ordinary legislative procedure for adoption by the Council and the European Parliament. 
For indicative OELs, it happens through a Commission directive. 

Change in the process: No 

Proximity  to  ECHA  mandate:  The  task  is  currently  already  performed  by  ECHA  via  an 
Service Level Agreement (SLA) and is a good fit with its core mandate.  

Main risks and opportunities: Resources in ECHA staffing are a limiting factor to do more 
OELs proposals. Capacity of the RAC secretariat is also a limiting factor.  

Projected impact on ECHA: 

•  ECHA Committees/bodies: high impact. The task generates major impact on the setup 

/ organisation / staffing of Committees/bodies due to the (additional) workload 

•  ECHA data model  and  IT infrastructure:  low impact. The task  can be implemented 

with adjustments / configuration of existing data structures and IT systems 

•  ECHA key experts: high impact. The task heavily relies on expert competencies, which 
are limited within ECHA and also critical to REACH/CLP/BPR regulatory tasks 

Workload and resource implications: 

Current workload and resources used: 

The number of RAC opinion on OELs varies between 0 and 3 opinions per year, with average 
of 1.5 opinion per year.   

Number of RAC opinions on OELs per year  

RAC opinion on 

2016  2017  2018  2019 

2020 

2021 

2022 

Occupational 
limits (OELs) 

exposure 

0 

2 

3 

0 

2 

2 

ECHA  provides  scientific  advice  for  the  setting  of  Occupational  Exposure  Limits  under  a 
Service  Level  Agreement  (SLA)  with  DG  EMPL.  To  assess  5  substances  annually,  ECHA 
receives 4 CA posts and in total EUR 975 000 that includes resources for those 4 CA posts.  

The current resources spent by the Commission can be summarized as follows: 

DG EMPL – ECHA Service Level Agreement  

4 FTEs (4 CAs) 

Operational budget 

EUR 575 000/year 

Through the SLA this activity does not  currently contribute to  the staff  cost  of running the 
Agency,  although  it  contributes  to  Infrastructure  and  Operational  costs  (administrative 
overhead or IT development). 

Current budget line: Budget line of DG EMPL 

Future workload and resource needs: 

The Commission intends to stop the arrangement via a SLA and formally assign this task to 
ECHA  by  enshrining  it  in  its  mandate.  The  normal  resource  needs  for  REACH  restriction 
dossier, which includes also socio-economic assessment and SEAC opinion is 1 (light dossier) 
-  1.5  (complex  dossier)  FTEs.  As  the  OEL  derivation  does  not  require  socio-economic 
assessment  nor  SEAC  opinion  and  is  principle  lighter  than  restriction  dossier,  the  average 
resource needs for one OEL is 0.8 FTEs. The Commission wishes to get at least 5 OELs per 

191 

 
 
 
  
year, which requires at least 4 FTEs per year. Overhead of 15% is required to contribution for 
common component of IT tool development (data submission, processing, output), which is 
additional 0.6 FTE, and overhead of 15 % is required to contribution for horizontal support 
(governance, enablers, administrative overhead), which is additional 0.6 FTE. In total, it makes 
5.2 FTEs 

Summary of resource needs for scientific opinions on OELs: 

Agency 

Summary of tasks 

ECHA 

Preparation of 5 dossiers/year with proposal 
for OEL 

Financial 
resource needs: 

Public consultation 

RAC opinion on the 5 dossiers per year and 
input from the public consultation  

Human resource 
needs: 

2024: EUR 0  
2025: EUR 0 
2026: EUR 200 000 
2027: EUR 200 000 
2028: EUR 200 000 
2024:  0 TA, 0 CA 
2025:  3 TA, 2 CA 
2026:  3 TA, 2 CA 
2027:  3 TA, 2 CA 
2028:  3 TA, 2 CA 

Future budget line: DG Employment 

Candidate for funding: No 

31.  REACH REGULATION (1907/2006) 

Responsible body: 

Currently: ECHA 

(Re-)attribution planned to: ECHA (changes in tasks) 

Legal basis for reattribution: Revision of REACH regulation  

Type of task: New or modified existing tasks 

Brief task overview: 

1.  Registration 
2.  Authorisation 
3.  Restriction  
4.  Evaluation  
5.  Enforcement  

Detailed process description: 

Change in the process: Yes 

Task 1 Registration 

Additional information requirements are foreseen to enable the identification and regulation of 
substances, in particular:  

•  endocrine disruptors and persistent substances, for which new hazard classes have been 

recently created in the CLP Regulation;    

•  polymers  will  be  added  to  the  scope  of  REACH  (notification  obligation  for  all 
polymers, registration only for those polymers which are more likely to be hazardous);  

192 

 
 
 
 
 
•  chemical safety assessment will be made stricter through a so-called “mixture allocation 
factor”  to  take  into  account  multiple  exposure  to  different  chemical  substances  (so 
called “cocktail effect”). It will initially only apply to high tonnage substances and with 
some opt-out possibilities under certain conditions only and if  specific risk assessments 
taking  into  account  multiple  exposure  are  not  already  provided  in  the  registration 
dossier;  

•  a chemical safety assessment will be required for substances in the 1-10 tonnage band.  

Task 2 Authorisation  

REACH authorisation, with its system of applicant by applicant decisions on allowing or not 
the use of the concerned substances, will be replaced by a simpler, less granular system. Details 
are still under discussion and include considerations of establishing a system calling for early 
information on use, exposure and alternatives, notably from downstream uses, to inform the 
decision on the best regulatory approach per substance.  

Additionally, the concept of essential uses will be implemented to take into account the needs 
of society (essential uses) or push to faster phase-out of substances for non-essential uses.   

Task 3 Restriction  

Where  risks  are  obvious,  simpler  restriction  procedures  in  the  so-called  “Generic  Risk 
management Approach” (GRA) will be extended from CMRs to new hazard classes and from 
consumer to professional uses.   

Likewise the authorisation process, the essential use concept will be implemented to derogate 
essential uses from the restrictions by taking into account the needs of society (essential uses) 
or to push for faster phase-out of substances for non-essential uses.  

Task 4 Evaluation  

Several provisions related to dossier and substance evaluation and its decision-making will be 
modified  to  enhance  efficiency  of  the  processes  and  re-focus  attention  of  testing  proposal 
examinations  from  volume-considerations  to  animal  testing  and  complex  studies.  Annually 
adopted  Community  Rolling  Action  Plan  will  be  replaced  with  lightweight  registry  of 
substance evaluations that would be justified based on hazard or risk considerations. ECHA 
will also be able to perform substance evaluation alongside MS competent authorities.   

Task 5 Enforcement 

A  number  of  actions  is  foreseen,  which  include  revoking  registration  in  case  of  persistent 
incompliance  or  expiry  of  the  technical  dossier,  Commission  audits  of  Member  States’ 
enforcement systems, improving customs controls, enabling OLAF to investigate breaches of 
REACH,  improving  access  to  justice  and  dealing  with  online  sales  from  third  countries  to 
consumers.   

Proximity  to  ECHA  mandate:  The  tasks  are  core  tasks  already  performed  by  ECHA  and 
therefore there is a good fit with its core mandate.  

Projected impact on ECHA: 

•  ECHA  Committees/bodies:  low  impact.  The  changes  in  the  tasks  on  restriction  and 

authorisation may slightly reduce the workloead of the committees  

•  ECHA data model and IT infrastructure: medium impact. The task can be implemented 

with adjustments / configuration of existing data structures and IT systems 

193 

 
 
•  ECHA key experts: high impact. The task heavily relies on expert competencies, which 
are limited within ECHA and also critical to REACH/CLP/BPR regulatory tasks 

Workload and resource implications: 

Current workload and resources used: 

Current budget line: Budget line of DG GROW 

Future workload and resource needs: 

Task 1 Registration  

Changes in Uses and exposure will require: 

•  Unquantified costs to ECHA to update guidance and IT tools (one-off direct 

administrative costs);  

•  EUR 160 000 costs to ECHA for additional manual Technical Completeness Check 

(recurrent direct administrative costs).  

Changes on registration requirements for polymers:  

The impact assessment estimates that the registration of polymers will entail additional EUR 
141  million  for  ECHA  (one-off  direct  administrative  costs).  ECHA  has  provided  a  more 
detailed breakdown of costs and FTEs, according to their own estimates:   

•  Capacity building and guidance development (industry and authority): 5-10 FTE 

annually from 2024 until 2033, EUR 0.9-1.5 million  

•  Notification, incl. support to industry: 10-15 FTE in 2027, 10-20 FTE in 2028, 2029 

and 2030, and 10-15 FTE in 2031, marginal onwards, EUR 3 million  

•  Developing grouping criteria: 5-10 FTE annually from 2029 to 2032, EUR 1.5-2 

million  

•  Registration, incl. support to industry: between 10 and 60 FTE annually from 2031 

onwards, EUR 4-5 million  

2024  2025  2026  2027   2028   2029   2030   2031   2032   2033   2034   2035   2036   2037   2038  

Activity  

unit      

Capacity  

FTE  5-10  5-10  5-10  5-10   5-10   5-10   5-10   5-10   5-10   5-10      

Notification  

FTE     

Grouping   FTE     

Registration  FTE     

10-
15  

10-20  10-20  10-20  10-15  small  small  small  

5-10   5-10   5-10   5-10      

10-15  15-20  30-45  35-65  35-60  35-65  35-60  25-35  

Total (app)  

FTE  5-10  5-10  5-10  

15-
25  

15-30  20-40  20-40  30-50  25-40  35-55  35-65  35-60  35-65  35-60  25-35  

Capacity   Euro     

€ 0.9-1.5 million  

Notification  Euro     

€ 3 million  

Grouping   Euro     

Registration  Euro     

€ 1.5 - 2 million  

€ 4 - 5 million  

194 

 
 
 
   
   
   
   
   
   
   
 
 
 
 
 
 
 
 
   
   
   
   
   
   
   
   
   
   
   
   
   
   
   
   
   
   
   
   
   
   
   
   
   
   
 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
   
   
   
   
   
   
   
   
   
   
   
   
   
   
   
   
   
   
   
   
   
   
   
   
   
   
   
   
   
   
   
Task 2 Authorisation   

No change in resource needs expected as a result of the revision 

Task 3 Restriction  

No change in resource needs expected as a result of the revision 

Task 4 Evaluation  

Required  evaluation  resources  are  to  an  important  degree  proportional  to  the  registration 
situation (number of registrations, changes to information requirements) and the ambition level 
applied (compliance check strategy e.g. number of compliance checks).   

While an assessment of currently ongoing Joint Evaluation Action Plan is only expected at its 
finalisation in 2027, until which time the current ECHA resources for evaluation are required 
at current level, it is generally considered that afterwards the proportion of resources working 
on present and incoming registrations would be freed. On the other side, additional resources 
to assess and address efficiencies in new polymer registrations will be required after 2031 (see 
above).   

While  no  quantified  resource  estimate  could  be  made  for  the  application  of  revocation 
processes and efficiency measures, it is considered that new needs are offset by the efficiency 
gains during evaluations and in their follow-up. Similar would apply for the expected increase 
in  testing  proposals  but  ability  for  a  lighter  process.  The  exception  is  required  additional 
resource for ECHA’s contribution to substance evaluations.   

Agency   Summary of tasks  

ECHA   Dossier and substance Evaluation:  

 ECHA’s contribution to substance 
• 
evaluations is expected at the level of 
contribution of a larger Member State 
(e.g. 3 substances/year, estimated to 
require 4.5 FTE3)  

Resource needs  

Note: these are 
additional resource 
needs for the 
ongoing processes  

2027 
onwards:  4.5 
FTE   

The evaluation processes are closely tied with the Member State Committee, whose main task 
is to assess the evaluation decisions. The changes will not require new capacity or change the 
nature  of  the  work.  The  number  of  evaluation  decisions  to  be  taken  is  not  expected  to 
importantly  change  (within  +-20%);  any  increase  in  testing  proposal  examination  decisions 
that might come would be associated with likely more simple content from lower tier animal 
testing.  

Task 5 Enforcement  

External Audit Capacity:   

•  Costs for ECHA Secretariat for Audit Capacity concerning REACH only, in the range 
of 0.1 to 0.13 FTE, i.e. from 21.5 working days to 29, which would amount to annual 
costs for ECHA Secretariat between around EUR 11 481 to 15 486 (recurring annual 
costs).   

195 

 
 
 
  
  
  
•  Costs for ECHA Secretariat for External Audit Capacity covering REACH and CLP, in 
the range of 0.1 to 0.15 FTE, i.e. from 21.5 working days to 32, which would amount 
to annual costs for ECHA Secretariat between around EUR 11 481 to 17 088 (recurring 
annual  costs),  or  EUR  225  000  to  335  000  over  30  years.  These  are  related  to 
administrative  support  to  discussions  in  Forum  that  may  take  place  in  relation  to 
Commission audits of MSs control systems.  

•  Forum: some costs will be incurred as it can be expected that in some Forum meetings 
(maybe  once  per  year)  an  agenda  point  may  be  included  to  discuss  either  the 
Commission programme for audits or the outcome of audits/controls carried out by the 
Commission.  

Customs:  

•  Costs for ECHA Secretariat to make the interconnection, under the responsibility of the 
Commission, of ECHA electronic systems with national single window environments 
for  customs  through  the  EU  Single  Window  Environment  for  customs,  for  the 
automated  controls  of  registrations,  authorisations  (and  restrictions).  The  budget  is 
estimated at about EUR 100 000.   

•  The workload in ECHA to handle this development, its maintenance, and potentially 
the  updates  of  company  accounts  by  importers  and  only  representatives  (around  14 
000), the inquiries from companies, as well as the support to the work of the ECHA 
Forum triggered by these new measures is estimated together at around 1,6 FTEs  

The resource needs for the implementation of the revised obligations under REACH should be 
absorbed by the existing resources for REACH and CLP. 

Summary of resource needs for REACH revision: 

Agency 

Summary of tasks 

ECHA 

Implementing  

•  Registration, 
•  Authorisation  
•  Restriction  
•  Evaluation  
•  Enforcement 

Future budget line: DG GROW 

Candidate for funding: No 

Financial resource 
needs: 

Human resource 
needs: 

2024: EUR 0  
2025: EUR 0 
2026: EUR 0 
2027: EUR 0 
2028: EUR 0 
2024:  0 TA, 0 CA 
2025:  0 TA, 0 CA 
2026:  0 TA, 0 CA 
2027:  0 TA, 0 CA 
2028:  0 TA, 0 CA 

32.  COSMETIC PRODUCTS REGULATION 

Responsible body: 

Currently: Commission with the support of the SCCS committee 

(Re-)attribution planned to: ECHA 

Legal basis for reattribution: revision of the Cosmetic Products Regulation (1223/2009) 

Type of task: existing 

196 

 
 
 
 
 
Brief task overview:  

(1) Safety assessment of chemicals used as ingredients in cosmetic products underlying the 

authorisation of colorants, preservatives and UV-filters  

(2) Opinion  to  the  Commission  underlying  the  prohibition  or  restriction  of  substances 

where concerns are raised due to potential risk to human health 

(3) Safety  assessment  of  chemicals,  classified  as  CMR,  used  as  ingredients  in  cosmetic 

products, when an application for exemption was introduced, 

(4) Opinion to the Commission on the safety of nanomaterials   

(5) Preparation  of  Notes  of  Guidance  for  the  testing  of  cosmetic  ingredients  including 

nanomaterials,  non-animal testing methodology, and their safety evaluation 

Detailed process description: 

Current process: 

The  Cosmetic  Products  Regulation  requires  that  the  responsible  persons  and,  under  certain 
circumstances, the distributors of cosmetic products notify electronically their products before 
placed on the European market through the Cosmetic Products Notification Portal (CPNP). The 
information to be submitted is specified in Article 13 as follows: 

- 

- 

- 
- 
- 
- 

- 

- 

the  category  of  cosmetic  product  and  its  name  or  names,  enabling  its  specific 
identification;  
the name and address of the responsible person where the product information file is 
made readily accessible;  
the country of origin in the case of import;  
the Member State in which the cosmetic product is to be placed on the market;  
the contact details of a physical person to contact in the case of necessity 
the  presence  of  substances  in  the  form  of  nanomaterials,  and  their  identification 
including  the  chemical  name  (IUPAC)  and  other  descriptors  and  the  reasonably 
foreseeable exposure conditions;  
the  name  and  the  Chemicals  Abstracts  Service  (CAS)  or  EC  number  of  substances 
classified as carcinogenic, mutagenic or toxic for reproduction (CMR), of category 1A 
or 1B, under Part 3 of Annex VI to Regulation (EC) No 1272/2008;  
the frame  formulation allowing for prompt and appropriate medical  treatment in  the 
event of difficulties. 

The CPNP is accessible to competent authorities, European poison centres, cosmetic products 
responsible persons and distributors of cosmetic products. 

The  Cosmetic  Products  Regulation  requires  that  a  cosmetic  product  made  available  on  the 
market  shall  be  safe  for  human  health  when  used  under  normal  or  reasonably  foreseeable 
conditions of use. In order to demonstrate that, the responsible person shall, prior to placing a 
cosmetic  product  on  the  market,  ensure  that  the  cosmetic  product  has  undergone  a  safety 
assessment on the basis of the relevant information and that a cosmetic product safety report is 
set  up  in  accordance  with  Annex  I.  The  Commission  shall  adopt  appropriate  guidelines  to 
facilitate, in particular SMEs, to produce the cosmetic product safety report.  

Taking  into  consideration  the  impact  of  the  chemical  ingredients  on  human  health,  the 
Cosmetic Products Regulation lays down limitations and requirements for the use of substances 
in cosmetic products. The rules are listed in Articles 14-17 and the following annexes: 

197 

 
 
•  Annex II - List of substances prohibited in cosmetic products 
•  Annex III - List of substances restricted in cosmetic products  
•  Annex IV - List of colourants allowed in cosmetic products 
•  Annex V - List of preservatives allowed in cosmetic products 
•  Annex VI - List of UV filters allowed in cosmetic products 

Certain groups of substances, i.e. colorants, preservatives and UV-filters must be authorised by 
the Commission, i.e. placed on the respective annex (IV, V or VI), prior to their use in cosmetic 
products. Certain subtances are prohibited (Annex II) and cannot be used in cosmetic products 
and certain substances are restricted (Annex III) and they can be used only when fulfilling the 
conditions of the restriction.  

The safety assessment of the cosmetic ingredients (substances) in the EU is performed by the 
Scientific Committee on Consumer Safety (SCCS). It is based on safety dossiers submitted by 
applicants  (individual  company/associations  or  by  competent  authorities)  or  by  the 
Commission. Based on its opinions, Commission may decide to amend the relevant Annexes. 
The  safety  of  cosmetic  products  with  all  their  ingredients  is  evaluated  by  “a  person  in 
possession of a diploma or other evidence of formal qualifications awarded on completion of 
a university course of theoretical and practical study in pharmacy, toxicology, medicine or a 
similar discipline” (Article 10(2) of the Cosmetic Products Regulation)  before placing them 
on the EU market. 

Task 1: Process for the authorisation of colorants, preservatives and UV-filters (including in 
nano forms) is as follows: 

1.  The amendment of the annexes IV, V or VI of the Cosmetic Products Regulation and 
associated technical and scientific work is initiated by the submission of a safety 
dossier by economic operators (applicant)  to the Commission. 

2.  Commission evaluates the completeness of the dossier and prepares a mandate to the 

SCCS. 

3.  SCCS performs a risk assessment (9-12 months). The preliminary Opinion is 

published and open for comments (4-8 weeks) before being finalised. A final opinion 
is published on the SCCS’ website.  

4.  Commission prepares a Working Document based on the final SCCS Opinion and 
shares it for discussion with the members of the Working Group on Cosmetic 
Products (participants: MS, Industry, SMEs and civil society organisations). 

5.  Commission prepares a Draft Regulation.  
6.  Draft Commission Regulation is discussed with the Standing Committee on Cosmetic 

Products, which comprises of MS authorities and the Commission. 
7.  TBT notification is launched with a commenting period of 2 months. 
8.  MS vote in the Standing Committee on Cosmetic Products (comitology) on the draft 

Commission Implementing Regulation. 

9.  Scrutiny period by the Council and the European Parliament of 3 months. 
10. Adoption of the Regualtion by the Commission and publication in the Official Journal 

of the EU. 

Task 2: Process for prohibition or restriction of a substance used in cosmetic products where 
concerns are raised due to a potential risk to human health is as follows: 

1.  The Commission may amend the annexes II and VI of the Cosmetic Products 

Regulation (CPR)  if concerns for human health due to the use of a substance in 
cosmetics were raised by e.g. Member States, economic operators (industry, SMEs) or 

198 

 
 
civil society organisations (NGOs).  

2.  The Commission evaluates the information/data gathered and prepares a mandate to 

the SCCS. 

3.  SCCS performs a risk assessment (9-12 months). The preliminary Opinion is 

published and open for comments (4-8 weeks) before being finalised. A final opinion 
is published on the SCCS’ website.  

4.  The Commission may  prepare a Working Document based on the final SCCS 
Opinion and share it for discussion with the members of the WG on Cosmetic 
Products (participants: MS, Industry, SMEs and civil society organisations). 

5.  The Commission prepares a Draft Regulation.  
6.  The draft Commission Implementing Regulation is discussed with the Standing 

Committee on Cosmetic Products. 

7.  TBT notification is launched with a commenting period of 2 months. 
8.  MS vote in the Standing Committee on Cosmetic Products (comitology) on the draft 

Commission Implementing Regulation. 

9.  Scrutiny period by the Council and the European Parliament of 3 months. 
10. Adoption of the Regualtion by the Commission and publication in the Official Journal 

of the EU 

Task  3:  The  use  of  CMR  substances  (category  1A,  1B,  or  2  under  CLP)  is  prohibited  in 
cosmetic  products,  apart  from  “exceptional”  cases.  This  prohibition  is  implemented  by 
amending  Annex  II-VI  of  the  Regulation.  Once  a  substance  receives  its  harmonised 
classification as CMRs cat 1A, 1B or 2 under CLP regulation, the Commission must update 
the annexes of the CPR within 15 months. There is no involvement of SCCS in this process, as 
there is no safety assessment performed except in the case of derogation requests. Economic 
operators can, on a voluntary basis, prepare and submit safety dossiers to defend the use of a 
substance in cosmetics. In such a case the Commission  can launch ‘calls for data’ in order to 
acquire as much information as possible for a full risk assessment.  

If there is a request from industry for derogation, then the Commission mandates the SCCS to 
perform  a  safety  assessment  and  following  the  outcome  of  the  SCCS  assessment  the 
Commission may amend Annexes III - VI.   

Task 4: Cosmetic products containing nanomaterials other than colourants, preservatives and 
UV-filters require a specific notification on the CPNP 6 months before they are placed on the 
market. If the Commission has concerns regarding the safety of a nanomaterial, it may request 
the SCCS to perform a risk assessment. The SCCS may also use information gathered from 
published literature and/or received from other stakeholders as a result of the Commission's 
call  for  data.  The  SCCS  has  6  months  to  deliver  its  final  opinion.  In  cases  where  further 
data/clarifications  are  needed,  the  6-months  clock  starts  again  once  the  necessary 
data/information is provided by the applicant. 

Task 5: The SCCS, with involvement of the Commission updates approximately every other 
year  a  technical  guidance  document  concerning  different  aspects  of  testing  and  safety 
evaluation  of  cosmetic  substances  (called  SCCS  Notes  of  guidance’).  The  emphasis  of  this 
guidance is on cosmetic ingredients, including nanomaterials although some guidance is also 
indirectly  given  for  the  safety  assessment  of  finished  products.  It  is  designed  to  provide 
guidance  to  public  authorities  and  to  the  economic  operators  (safety  assessors)  to  improve 
harmonised compliance with the current cosmetic EU legislation.  

Administrative support for the SCCS 

199 

 
 
The  SCCS  is  currently  managed  by  DG  SANTE  within  the  Commission,  which  provides 
secretariat services for the committee. The Secretariat is responsible for providing scientific 
and administrative support necessary to facilitate the efficient functioning of the Committee, 
to monitor compliance with the Rules of Procedure, particularly in relation to the requirements 
for  excellence,  independence,  commitment,  confidentiality  and  transparency,  to  ensure 
communication on the Committees' activities, the appropriate stakeholder dialogue, publication 
of the opinions and other relevant documents. Moreover, the Secretariat provides support to 
the Committee and organises and applies quality control of the opinions as far as completeness, 
consistency, clarity, correspondence with requests and with editorial standards are concerned. 
Further tasks can be found in the rules of procedure. 

Changes in the process:  

It is envisaged that the SCCS will become part of ECHA, and therefore ECHA will take over 
the secretarial tasks of the committee. It is important that the flexible arrangements are put in 
place to allow the best integration of the  SCCS in ECHA and, in particular, in view  of any 
future reorganisation of the Agency’s bodies, that would take into account the experience with 
SCCS work in ECHA and the need to increase the capacity of the existing committees in ECHA 
as a consequence of number of reattributions.  

In view of the targeted revision of the CPR, apart from CMRs, additional hazard classes will 
be subject to risk management measures covering substances classified as endocrine disruptors, 
and  the  separate  process  will  be  established  to  examine  the  safety  of  substances  that  could 
affect the respiratory system and chemicals toxic to a specific target organ toxicant (STOT), 
which  will  also  require  the  safety  assessment  by  the  SCCS.  This  is  expected  to  result  in  a 
significant  increase  in  the  workload  of  the  SCCS  and  the  supporting  work  of  the  ECHA’s 
secretariat. 

Proximity to ECHA mandate: The risk assessment of chemicals including data management 
and  facilitating  the  work  of  committees  is  a  core  part  of  the  ECHA  mandate.  The  task  is 
therefore closely related to ECHA’s core mandate and ECHA has the needed data, competences 
and  expertise  to  perform  the  task.  Synergies  could  be  achieved  if  the  work  of  the  SCCS 
committee  would  be  translocated  into  ECHA,  both  in  terms  of  efficiencies,  as  in  terms  of 
coherence of scientific opinions.    

Projected synergies and added value of reattribution: 

Type 

Synergies 

Reuse of 
capabilities 

High 

Process and expertise: ECHA already performs similar work 
on restrictions, derogations and setting of limit values under 
REACH and other legislation. Several key capacities can be 
reused/reinforced: 

-  Hazard, risk and exposure assessment 
-  Exposure limit value definition 
-  Committee opinion development 
-  Existing IT capabilities for industry dossier 
submission, stakeholder consultation and 
dissemination 

200 

 
 
Re-use of data  High 

Reuse of data collected under other chemical legislation, 
especially REACH & CLP, with a focus on CMRs endocrine 
disruptors or other hazardous chemicals. 

Low 

High 

High 

Workload 
balancing 

IT tools: 
automation 
and 
economies of 
scale 

Support 
services: 
economies of 
scale 

With an estimated workload of 11 opinions to be worked on in 
parallel, there is little room for workload balancing.  

Industry actors can submit their derogation requests reusing 
existing ECHA submission tools, at the same time automating 
the existing process. In addition, reuse of IT capabilities for 
case management, public consultation, interaction with 
Member States, regulatory intentions management and data 
dissemination. 

Reuse of scientific support services (e.g. committee 
secretariat, prioritisation and grouping of substances, 
substance identification, data management and dissemination). 
Reuse of administrative services. 

Type 

Added value 

Scientific 
consistency 

High 

Independence  High 

Opportunity to align priority setting, timeline, process and 
methodology with other related legislation to improve 
coherence in the scientific advice provided to the 
Commission. Reuse of data collected under other chemical 
legislation. Opportunity to promote risk assessment 
methodologies based on non-animal data beyond cosmetic 
area. 

Moving the SCCS and its tasks to the European Chemicals 
Agency will continue ensuring the strict separation between 
science and policy. ECHA and its committees work under 
strict conflict of interest avoidance rules, improving 
guarantees of independent scientific advice to the 
Commission. 

Transparency  High 

ECHA’s involvement will bring additional transparency to the 
process: 

-  Overall process transparency 
-  Publication of regulatory intentions of EU authorities 
improves predictability for industry stakeholders 

-  Public consultation/call for evidence 
-  Stakeholder involvement/observer status 
-  Dissemination of scientific data and outcomes 

Main risks and opportunities: The high impact on the ECHA committee structure needs to 
be addressed and the existing expertise in the SCCS committee should be retained to the extent 
possible.  There  is  a  need  to  ensure  continuity  of  the  opinion  making  to  ensure  undisturbed 

201 

 
 
 
implementation of the Cosmetic Products Regulation. Working methodologies would need to 
be adapted.  

Projected impact on ECHA: 

•  ECHA Committees/bodies: high impact. The task generates major impact on the setup 
/ organisation / staffing of Committees/bodies due to the additional workload and due 
to a new committee 

SCCS 

# of opinions per year 

rapporteur 

Type of opinion 

Opinions 

11 

Notes of guidance  1 

SCCS member 

SCCS member  

•  ECHA data model  and  IT infrastructure:  low impact. The task  can be implemented 

with adjustments / configuration of existing data structures and IT systems 

•  ECHA key experts: high impact. The task heavily relies on expert competencies, which 
are limited within ECHA and also critical to REACH/CLP/BPR regulatory tasks 

Projected workload and resource implications: 

Current workload and resource use: 

SCCS delivers on average 11 final opinions per year (see table below), while it has a maximum 
of  20  opinions  in  the  pipeline  at  any  given  moment  based  on  its  current  composition  and 
structure.  The  SCCS  is  used  mainly  to  support  the  Cosmetic  Products  Regulation  but  has 
provided scientific advice for other sectors in the past, albeit rarely.  

Number of SCCS opinions  

2016 

7 

2017 

9 

2018 

13 

Number of 
opinions 

2019 

12 

2020 

6 

2021 

19 

DG GROW staff has one policy officer (1 FTE) dedicated to the work of the SCCS in relation 
to the implementation of the CPR. The proposed reorganisation will not change the need for 
the FTEs from the side of DG as it is not involved in the safety assessment as such.  

The  secretariat  of  the  scientific  committees  hosted  by  DG  SANTE  employs  4  FTE  of  DG 
SANTE  and  2  additional  FTEs  of  external  interim  staff  (for  technical  and  administrative 
support  like  literature  search,  editing  and  proofreading  of  opinions,  website  mastering, 
assistance  for  the  Health-EU  newsletter,  dissemination  activities).  The  staff  of  6  FTEs  is 
equally split over two committees (i.e., SCCS and SCHEER), which means that 3 FTEs are 
used to support work of SCCS. The SCCS is structured into 3 working groups that deal with 
several  opinions  at  the  same  time  (sometimes  up  to  20).  Usually,  each  SCCS  member  is  a 
rapporteur for 1 opinion at a time, however, quite often and in view of their expertise some 
members are rapporteurs for multiple opinions in parallel. External experts sometimes can also 
be nominated as rapporteurs. 

The  operational  costs  for  SCCS  and  SCHEER  (that  includes  special  indemnities, 
accommodation,  daily  allowances,  travel  costs,  reimbursement  for  rapporteurship,  etc) 
operated by the Commission were EUR 2 883 030 for 6 years (2016-2021), which makes it 
approximately EUR 240 000 per year per committee. It must be noted that the operational costs 

202 

 
 
 
 
 
 
 
 
 
 
varies per year. For example, in 2019 the operational costs were EUR 370 000, which then 
went down because of pandemic measures.  

The resource use can be summarized as follow:  

DG SANTE secretariat 

3 FTEs (2 internal + 1 external)  

SCCS committee 

100% of membership capacity (14 members + 4 external experts) 

Yearly operational budget for members of the committee was on 6 year average 
(2016-2021) EUR 240 000 per year  

Total 

Ca. 3 FTEs 

(to convert the cost of consultants into FTEs, the cost of 1 FTE consultant is estimated at ca. 
EUR 66 000 annually) 

Such Commission resources do not include contributions to the administrative overhead of 
the Commission (HR, Finance, IT tools, etc.). 

Current budget line: DG SANTE + DG GROW 

Future workload and resource needs: 

Because of the planned introduction of new risk management measures to cover substances 
classified as endocrine disruptors, and the process for examining the safety of substances that 
could  affect  the  respiratory  system  and  chemicals  toxic  to  a  specific  target  organ  toxicant 
(STOT), it is expected that the number of exemption requests might grow significantly and that 
there will be a need for more than the current average of 11 opinions per year, with more than 
up to 20 opinions in the pipeline at any given moment. However, in view of the maximum 
capacity of the SCCS based on its current composition the overall number of assessments per 
year may not change dramatically.  

If the current ECHA estimation of resources is applied to the complexity of dossier reviewed 
by the SCCS, we can extrapolate the following future allocation of FTEs: 0.35 FTE for low 
complexity dossier (4 dossiers out of 11 which would require 1.4 FTE), 0.5 FTE for average 
complexity (4 dossiers out of 11 would require 2 FTE) and 0.65 FTE for complex dossier (3 
dossiers out of 11 which would require 1.95 FTE).  For 11 opinions per year this makes 5.4 
FTEs.  Overhead  of  15%  is  required  to  contribution  for  common  component  of  IT  tool 
development  (data  submission,  processing,  output),  and  overhead  of  15  %  is  required  to 
contribution for horizontal support (governance, enablers, administrative overhead), which is 
additional 1.6 FTE. In total, it makes 7 FTEs. In addition, there is a need to cover travelling, 
accommodation, contingency costs related to members of the SCCS, in total some EUR 300 
000/year.   

Summary of resource needs for cosmetic product regulation: 

Agency 

Summary of tasks 

ECHA 

Assessment for Restriction/prohibition of 
substances  

Financial resource 
needs: 

Assessments for authorisation of 
substances and exemption requests 

2024: EUR0  
2025: EUR 0 
2026: EUR 300 000 
2027: EUR 300 000 
2028: EUR 300 000 

203 

 
 
 
 
 
Update of the Guidance document  

Human resource 
needs: 

2024:  0 TAs, 0 CAs 
2025:  7 TAs, 0 CAs 
2026:  7 TAs, 0 CAs 
2027:  7 TAs, 0 CAs 
2028:  7 TAs, 0 CAs 

Future budget line: DG GROW 

Candidate for fees:  No 

33.  SCIENTIFIC COMMITTEES AND THEIR SECRETARIAT (SCCS/SCHEER) 

Responsible body: 

Currently:  Commission  (DG  SANTE)  providing  the  secretariat  and  operating  the  two 
committees 

(Re-)attribution planned to: chemical work of both Committees to ECHA and partly also to 
EFSA and EEA; non-chemical work to the Scientific Advisory Mechanism (SAM), under DG 
RTD. 

Legal basis for reattribution: Revisions, omnibus regulation + Commission Decision 

Type of task: existing 

Brief task overview: Providing secretariat for the Scientific Committee on Consumer Safety 
(SCCS) and on Health, Environmental and Emerging Risks (SCHEER) and providing opinions 
on variety of chemical and non-chemical related subjects.  

Detailed process description: 

Current process: 

When preparing policy or proposals related to consumer safety, health and the environment, 
the  Commission  relies  on  two  independent  Scientific  Committees  to  provide  it  with  sound 
scientific advice and draw its attention to new and emerging problems.  

For this purpose, the Commission Decision C(2015)5383[1] established the following scientific 
committees:  

•  Scientific Committee on Consumer Safety (SCCS), and  
•  Scientific Committee on Health, Environmental and Emerging Risks (SCHEER). 

Formal mandate 

The SCCS on request of Commission services shall provide opinions on questions concerning 
health and safety risks, notably chemical, biological, mechanical and other physical risks, of:  

1.  non-food consumer products such as  

- 

cosmetic  products  and  their  ingredients,  including  nanomaterials,  hair  dyes, 
fragrance ingredients, UV filters, preservatives, colorants, etc.;  

-  personal care and household products such as detergents; toys, textiles, clothing, 

etc.  

2.  services such as tattooing, artificial sun tanning, etc. 

The  SCHEER  on  request  of  Commission  services  shall  provide  opinions  on  questions 
concerning health, environmental and emerging risks.  

204 

 
 
 
 
1.  In particular, the Committee shall provide opinions on questions concerning emerging 
or  newly  identified  health  and  environmental  risks  and  on  broad,  complex  or 
multidisciplinary  issues  requiring  a  comprehensive  assessment  of  risks  to  consumer 
safety or public health and related issues not covered by other Union risk assessment 
bodies.  Examples  of  areas  of  activity  include  potential  risks  associated  with 
antimicrobial resistance, new technologies such as nanotechnologies, medical devices 
including  those  incorporating  substances  of  animal  and/or  human  origin,  tissue 
engineering,  blood  products,  fertility  reduction,  physical  hazards  such  as  noise  and 
electromagnetic fields, interaction of risk factors, synergic effects, cumulative effects, 
and  methodologies  for  assessing  new  risks.  It  may  also  be  invited  to  address  risks 
related to public health determinants and nontransmissible diseases.  

2.  The SCHEER Committee shall also provide opinions on risks related to pollutants in 
the environmental media and other biological and physical factors or changing physical 
conditions  which  may  have  a  negative  impact  on  health  and  the  environment,  for 
example  in  relation  to  air  quality,  waters,  waste  and  soils,  as  well  as  on  life  cycle 
environmental assessment.  

3.  Without  prejudice  to  the  competences  conferred  on  the  European  Chemical  Agency 
(ECHA) and other Union bodies undertaking risk assessment, it may also be invited to 
address questions relating to examination of the toxicity and eco-toxicity of chemical, 
biochemical and biological compounds whose use may have adverse effects for human 
health and the environment, including biocides. 

4.  In addition, the Committee will address questions relating to methodological aspect of 
the assessment of health and environmental risks of chemicals, including mixtures of 
chemicals, as necessary for providing sound and consistent advice in its own areas of 
competence as well as in order to contribute to the relevant issues in close cooperation 
with other European agencies. 

Work of Committees in practice 

The  SCCS  concentrates  mostly  on  the  risk  assessment  of  cosmetic  ingredients.  Opinions 
delivered  by  SCCS[2]  from  2013  till  today  were  exclusively  on  the  safety  of  chemicals  in 
cosmetics (nanomaterials, fragrances, hair dyes, preservatives, UV filters) or methodologies 
used for risk assessment of chemicals. 

The SCHEER’s work covers rather large and diverse areas. Opinions delivered by SCHEER 
between  2014  and  today  (see  table  below)  were  related  to  areas  of  environmental  risk 
assessment, medical devices, use of animals in laboratory testing, physical risks, public health 
(mainly tobacco), toys and rapid risk assessment.  

Table:  List  of  delivered  opinions  by  SCHEER  since  2014,  with  those  not  about  safety 
assessment of chemicals highlighted in green: 

Environmental risk assessment  
Opinion  on  Draft  Environmental  Quality  Standards  for  priority  substances  under  the  Water 
Framework Directive – 5-6 rings polyaromatic hydrocarbons (PAH) 
Opinion  on  Draft  Environmental  Quality  Standards  for  priority  substances  under  the  Water 
Framework Directive – Tributyltin compounds 
Opinion  on  Draft  Environmental  Quality  Standards  for  priority  substances  under  the  Water 
Framework Directive – Dicofol 
Opinion  on  Draft  Environmental  Quality  Standards  for  priority  substances  under  the  Water 
Framework Directive – PBDEs 

March 2023 

March 2023 

January 2023 

January 2023 

205 

 
 
  
Opinion  on  Draft  Environmental  Quality  Standards  for  priority  substances  under  the  Water 
Framework Directive – dioxins, furans and dioxin-like PCBs 
Opinion  on  Draft  Environmental  Quality  Standards  for  priority  substances  under  the  Water 
Framework Directive – HBCD 
Opinion  on  Draft  Environmental  Quality  Standards  for  priority  substances  under  the  Water 
Framework Directive – Triclosan 
Opinion  on  Draft  Environmental  Quality  Standards  for  priority  substances  under  the  Water 
Framework Directive – Mercury and its compounds 
Opinion  on  Draft  Environmental  Quality  Standards  for  priority  substances  under  the  Water 
Framework Directive – Heptachlor including heptachlor epoxide 
Opinion  on  Draft  Environmental  Quality  Standards  for  priority  substances  under  the  Water 
Framework Directive – Nickel and its compounds 
Opinion  on  Draft  Environmental  Quality  Standards  for  priority  substances  under  the  Water 
Framework Directive – Glyphosate 
Opinion  on  Draft  Environmental  Quality  Standards  for  priority  substances  under  the  Water 
Framework Directive – Hexachlorobutadiene 
Opinion  on  Draft  Environmental  Quality  Standards  for  priority  substances  under  the  Water 
Framework Directive – Ibuprofen 
Opinion  on  Draft  Environmental  Quality  Standards  for  priority  substances  under  the  Water 
Framework Directive – Fluoranthene 
Opinion  on  Draft  Environmental  Quality  Standards  for  priority  substances  under  the  Water 
Framework Directive – Nonylphenol 
Opinion  on  Draft  Environmental  Quality  Standards  for  priority  substances  under  the  Water 
Framework Directive – Diuron 
Opinion  on  Draft  Environmental  Quality  Standards  for  priority  substances  under  the  Water 
Framework Directive – Bisphenol A 
Opinion  on  Draft  Environmental  Quality  Standards  for  priority  substances  under  the  Water 
Framework Directive – Hexachlorobenzene 
Opinion  on  Draft  Environmental  Quality  Standards  for  priority  substances  under  the  Water 
Framework Directive – PFAS 
Opinion  on  Draft  Environmental  Quality  Standards  for  priority  substances  under  the  Water 
Framework Directive – Cypermethrin 
Opinion  on  Draft  Environmental  Quality  Standards  for  priority  substances  under  the  Water 
Framework Directive – Diclofenac 
Scientific Opinion on Groundwater quality standards for proposed additional pollutants in the 
annexes to the Groundwater Directive (2006/118/EC) 
Scientific Opinion on "Draft Environmental Quality Standards for Priority Substances under the 
Water Framework Directive" - Chlorpyrifos 
Scientific Opinion on "Draft Environmental Quality Standards for Priority Substances under the 
Water Framework Directive" - Carbamazepine 
Scientific Opinion on "Draft Environmental Quality Standards for Priority Substances under the 
Water Framework Directive" - Bifenthrin 
Scientific Opinion on "Draft Environmental Quality Standards for Priority Substances under the 
Water Framework Directive" - Azithromycin 
Scientific Opinion on "Draft Environmental Quality Standards for Priority Substances under the 
Water Framework Directive" - Clarithromycin 
Scientific Opinion on "Draft Environmental Quality Standards for Priority Substances under the 
Water Framework Directive" - Esfenvalerate 
Scientific Opinion on "Draft Environmental Quality Standards for Priority Substances under the 
Water Framework Directive" - Permethrin 
Scientific Opinion on "Draft Environmental Quality Standards for Priority Substances under the 
Water Framework Directive" - Deltamethrin 
Scientific Opinion on "Draft Environmental Quality Standards for Priority Substances under the 
Water Framework Directive" - Thiamethoxam 
Scientific Opinion on "Draft Environmental Quality Standards for Priority Substances under the 
Water Framework Directive" - Thiacloprid 

January 2023 

January 2023 

January 2023 

December 2022 

December 2022 

December 2022 

December 2022 

December 2022 

December 2022 

November 2022 

November 2022 

October 2022 

October 2022 

October 2022 

August 2022 

August 2022 

August 2022 

July 2022 

June 2022 

May 2022 

May 2022 

May 2022 

May 2022 

March 2022 

March 2022 

March 2022 

March 2022 

March 2022 

206 

 
 
Scientific Opinion on "Draft Environmental Quality Standards for Priority Substances under the 
Water Framework Directive" - Clothianidin 
Scientific Opinion on "Draft Environmental Quality Standards for Priority Substances under the 
Water Framework Directive" - Acetamiprid 
Scientific Opinion on "Draft Environmental Quality Standards for Priority Substances under the 
Water  Framework  Directive"  -  17-Alpha-Ethinylestradiol  (EE2),  Beta-Estradiol  (E2)  and 
Estrone (E1 
Scientific Opinion on "Draft Environmental Quality Standards for Priority Substances under the 
Water Framework Directive" - Erythromycin 
Statement II on emerging health and environmental issues (2022) 

Scientific Opinion on "Draft Environmental Quality Standards for Priority Substances under the 
Water Framework Directive" - Nicosulfuron 
Scientific Opinion on "Draft Environmental Quality Standards for Priority Substances under the 
Water Framework Directive" - Silver and its compounds 
Scientific Opinion on "Draft Environmental Quality Standards for Priority Substances under the 
Water Framework Directive" - Imidacloprid 
Potential  for  anaerobic  biodegradability  in  marine  and  freshwater  of  Linear  Alkylbenzene 
Sulphonates (LAS) 
Scientific  advice  on  Guidance  Document  n°27:  Technical  Guidance  for  Deriving 
Environmental Quality Standards 
Scientific advice on Proposed EU minimum quality requirements for water reuse in agricultural 
irrigation and aquifer recharge 
Potential  risks  to  human  health  and  the  environment  from  the  use  of  calcium  cyanamide  as 
fertiliser 
New conclusions regarding future trends of cadmium accumulation in EU arable soils 
Opinion on Synthetic Biology I, II and III - Risks to the environment and biodiversity related 
to synthetic biology and research priorities in the field of synthetic biology 
Opinion on Environmental risks and indirect health effects of mercury from dental amalgam 
(update 2014) 
Medical Devices  
Opinion on the safety of breast implants in relation to anaplastic large cell lymphoma 
Guidelines  on  the  benefit-risk  assessment  of  the  presence  of  phthalates  in  certain  medical 
devices covering phthalates which are carcinogenic, mutagenic, toxic to reproduction (CMR) 
or have endocrine-disrupting (ED) properties 
Scientific Advice on Evaluation of the availability of new scientific information on the safety 
of Poly Implant Prothèse (PIP) breast implants  
Scientific advice on the state of scientific knowledge regarding a possible connection between 
breast implants and anaplastic large cell lymphoma 
Opinion on the safety of medical devices containing DEHP-plasticized PVC or other plasticizers 
on neonates and other groups possibly at risk 
Opinion on the safety of surgical meshes used in urogynaecological surgery 
Opinion on the safety of dental amalgam and alternative dental restoration materials for patients 
and users 
Opinion on the safety of the use of bisphenol A in medical devices 
Opinion  on  the  safety  of  Metal-on-Metal  joint  replacements  with  a  particular  focus  on  hip 
implants 
Opinion on the safety of Poly Implant Prothèse (PIP) Silicone Breast Implants 
Non animal testing  
Opinion on the need for non-human primates in biomedical research, production and testing of 
products and devices (update 2017) 
Physical risks 
Opinion on the potential risks to human health of Light Emitting Diodes (LEDs) 
Opinion on Biological effects of UV-C radiation relevant to health with particular reference to 
UV-C lamps 
Opinion on Biological effects of ultraviolet radiation relevant to health with particular reference 
to sunbeds for cosmetic purposes 

207 

March 2022 

March 2022 

March 2022 

February 2022 

January 2022 

October 2021 

October 2021 

October 2021 

June 2020 

Sept 2017 

June 2017 

March 2016 

Nov 2015 
Sept  2014;  May 
2015; Nov 2015 
March 2014 

March 2021 
June 2019 

Sept 2017 

Oct 2017 

Feb 2016 

Dec 2015 
Apr 2015 

Feb 2015 
Sept 2014 

May 2014 

May 2017 

June 2018 
Feb 2017 

Nov 2016 

 
 
  
  
  
Final opinion on potential health effects of exposure to electromagnetic fields (EMF) 
Public health  
Opinion on Electronic cigarettes 
Opinion on the public health impacts and risks resulting from onshore oil and gas exploration 
and exploitation in the EU 
Final Opinion on Additives used in tobacco products (Tobacco Additives II) 
Rapid risk assessment 
Guidance  on  ad  hoc  rapid  risk  assessment  of  serious  cross-border  chemical  health  threats 
performed by the SCHEER 
Toys 
Final  Opinion  on  Toxicological  reference values  for  certain  organic  chemicals  emitted  from 
squishy toys with regard to adopting limit values under the Toy Safety Directive 2009/48/EC 
‘Chemicals in squishy toys’ 
Final Opinion on Tolerable intake of aluminium with regards to adapting the migration limits 
for aluminium in toys 
Opinion on Estimates of the amount of toy materials ingested by children 
Opinion on Chromium VI in toys 
Statements 
Statement I and II on emerging health and environmental issues (2018; 2022) 
SCHEER Statement on emerging health and environmental issues (2018) 

SCHEER Position Paper on Emerging Issues and the Role of the SCHEER (2018) 

Memorandum on weight of evidence and uncertainties - Revision 2018 

Position Statement on emerging and newly identified health risks be drawn to the attention of 
the European Commission 
Nanotechnologies 
Final opinion on Guidance on the Determination of Potential Health Effects of Nanomaterials 
Used in Medical Devices 
Final opinion on Nanosilver: safety, health and environmental effects and role in antimicrobial 
resistance 

Jan 2015 

April 2021 
Nov 2018 

Dec 2016 

Feb 2017 

June 2021 

Sept 2017 

April 2016 
Jan 2015 

Jan 2022 
December 2018 

June 2018 

June 2018 

November 2014 

Jan 2015 

June 2014 

The Rules of Procedure of the Committees are fully described here:  

https://ec.europa.eu/health/sites/health/files/scientific_committees/docs/rules_procedure_201
6_en.pdf.  

In  order  to  ensure  the  effective  functioning  of  the  Scientific  Committees,  these  Rules  of 
Procedure regulate the functioning of the Scientific Committees, their working groups, the role 
and responsibilities of members and experts, other activities related to the functioning of the 
Scientific Committees, as well as the role and responsibilities of their secretariat.  

The members of the SCCS and SCHEER are independent experts in various fields, selected 
after a public Call for Experts and appointed for a five-year term (current one until the end of 
2026). 

Changes in the process: 

The  SCCS  is  embedded  in  the  Cosmetics  regulation  as  a  risk  assessment  body  providing 
opinions to ensure safety of cosmetics products. In practice, SCCS serves exclusively to the 
implementation of the Cosmetic Products Regulation. The impact assessment accompanying 
the  Commission  Proposal  for  the  revision  of  the  Cosmetic  Products  Regulation  contains 
analysis of options for reattribution of SCCS’s tasks to ECHA. After the reattribution of work 
for cosmetics regulation to ECHA, there will be no need for DG SANTE operating the SCCS. 

208 

 
 
  
  
  
  
  
 
The SCHEER‘s work is diverse. One part of the SCHEER’s work relates to chemicals, namely 
under  the  Water  Framework  Directive/Environmental  Quality  Standard  Directive,  Toys 
Directive, Medical Devices Directive, Cross-Border Health Threats Regulation and Tobacco 
Directive. This can be re-attributed to the EU Agencies.  

Other part of work of the SCHEER covers diverse issues like electromagnetic fields, emerging 
issues in health and environment, medical devices (like hip or breast implants), safety of LED 
lights, UVC lamps and sunbeds, use of animals in laboratories, etc. This clearly does not fall 
under the area of chemicals and it does not really fit to any of the EU Agencies. Such work will 
be transferred to Scientific Advisory Mechanism – SAM, under DG RTD.  

The  SAM  consists  of  the  Group  of  Chief  Scientific  Advisors  (in  total  seven),  the  Science 
Advice for Policy by European Academics (SAPEA) consortium and the SAM secretariat. The 
SAM functions differently than the SCHEER. The basic difference is that the SCHEER directly 
gets  mandates  from  the  mandating  Directorates  General,  i.e.  policy  Unit  dealing  with 
legislative  proposals.  SAM  gives  scientific  advice  to  the  College  and  Commissioners  on 
broader issues through a request to the Commissioner for Research, Science and Innovation. 
The full SAM procedure is as follows:  

1.  The request for advice is initiated by members of the Commission through a request to 

the Commissioner for Research, Science and Innovation.  

2.  The Commissioner for Research, Science and Innovation is responsible for formulation 
of the request. The SAM secretariat in cooperation with the requesting service prepares 
a  scoping  paper.  The  Cabinet  of  the  Commissioner  for  Research,  Innovation  and 
Science consults the relevant Cabinets of the Members of the Commission on the final 
draft scoping paper. If agreed, the Advisors are notified by the SAM Secretariat. The 
final  decision  to  adopt  a  scoping  paper  lies  with  the  Commissioner  for  Research, 
Science and Innovation in cooperation with the Advisors. 

3.  Once the scoping paper with the related deadline has been adopted, the advisors appoint 
a lead member who asks SAM secretariat to request SAPEA to gather the evidence. 
SAPE collects and review the evidence and produces Evidence Review Reports (ERR). 
Expert  workshops  which  are  part  of  the  evidence  review  process  are  by  default 
organised by SAPEA. 

4.  In view of the evidence, the lead member/coordination group will draft the Advisors’ 
advice, also explaining existing uncertainties as well as minority views in science, if 
considered  relevant.  The  SAM  Secretariat  will  assist  the  preparation,  proof-reading, 
editing and formatting of the advice. 

5.  The Advisors will aim for adoption by consensus of its advice. A dissenting opinion by 
any member(s) of the Group of Chief Scientific Advisors will be noted. Once adopted, 
the  Chair  of  the  Advisors  will  send  the  advice  to  the  Commissioner  for  Research, 
Science and Innovation who will transmit it to the other Members of the Commission, 
including  to  the  President.  The  Director-General  for  Research  and  Innovation  will 
inform the relevant services. 

The way of working might differ, but the non-chemical topics of the SCHEER could fit well 
under the remit of the SAM, although targeted for a specific piece of legislation: 

•  Potential risks to human health of Light Emitting Diodes (LEDs) 
•  Biological effects of UV-C radiation relevant to health with particular reference to UV-

C lamps 

•  Biological effects of ultraviolet radiation relevant to health with particular reference to 

209 

 
 
sunbeds for cosmetic purposes 

•  Electronic cigarettes/tobacco additives 
•  Potential health effects of exposure to electromagnetic fields (EMF) 
•  Position Statement on emerging and newly identified health risks to be drawn to the 

attention of the European Commission 

•  Estimates of the amount of toy materials ingested by children 
•  Use of animals in laboratory testing  
•  Synthetic biology 

Proximity to Agencies’ mandate:  

For chemical work, see the proximity analysis under the Cosmetic Products Regulation, the 
Water  Framework  Directive/Environmental  Quality  Standard  Directive/Ground  water 
directive, Toys Directive, Medical Devices Directive, Cross-Border Health Threats Regulation 
and Tobacco Directive. 

For non-chemical work, Scientific Advice Mechanism (SAM) of the DG RTD could be the 
best solution as they already provide scientific advice to the College. The SAM will undergo a 
reorganization along with the revamping of the scientific advice of the new Commission (2024-
2029) with help of SG.  

Projected impact on Agencies: 

For  chemical  work,  see  the  analysis  of  projected  impact  on  Agencies  under  the  Cosmetic 
Products  Regulation,  the  Water  Framework  Directive/Environmental  Quality  Standard 
Directive/Ground water directive, Toys Directive, Medical  Devices Directive, Cross-Border 
Health Threats Regulation and Tobacco Directive. 

For non-chemical work, the projected impact on SAM is:  

•  SAM Committee/bodies: high impact. The task generates major impact on the setup / 

organisation / staffing of Committees/bodies due to the additional workload 

SAM 

# of opinions per 
year 

rapporteur 

Type of opinion 

Opinions on non-
chemical topics of 
SCHEER 

1 

SAM 
Secretariat 

•  SAM data model and IT infrastructure: low impact. The task can be implemented 

with adjustments / configuration of existing data structures and IT systems 

•  SAM key experts: low impact. The task can be accommodated with existing expertise 

in SAM  

Workload and resource implications: 

Current workload and resource use: 

In the past, the Secretariat was part of a whole Unit in DG SANTE Brussels and had up to 20 
FTEs.  After  the  Secretariat  of  the  Committees  moved  from  Brussels  to  Luxembourg,  the 
number of staff working for both Scientific Committees started to decline every year. Until 
October  2022,  the  Secretariat  of  both  SCCS  and  SCHEER  had  worked  with  its  minimum 

210 

 
 
 
 
 
 
 
capacity:  3  ADs  officials,  1  CA  and  2  external  person/contractor.  As  of  October  2022,  in 
anticipation of the reattribution of tasks, the secretariat was reduced further, to 2 ADs officials 
and  ½  CA.  The  current  Secretariat  estimates  that  minimum  number  would  be  3  FTE  per 
Committee (2 AD level and one secretary plus one external (contractor)). Maximum production 
capacity for both Committees together is production of up to 25 Opinions per year.  

Key figures of the Scientific Committees’ activity in term 2016-2021 are:   

SCs 

SCCS 

SCHEER 

ICCG 

Total 

No. of adopted final documents 

No. of meeting days* 

66 

29 

0 

95 

234 

268 

5.5 

507.5 

Number of opinions per Committee per year in term 2016-2021 are:  

YEAR 

4-12/2016 

2017 

2018 

2019 

2020 

2021 

TOTAL 

SCCS 

SCHEER 

7* 

9 

13 

12 

6 

19 

66 

2 

9 

6 

3 

1 

8 

29 

The  total  budget  spent  for  all  the  activities  was  EUR  3  964  190,89  for  term  April  2016  to 
December 2021:   

•  EUR 2 883 030,89 were spent for meeting costs - reimbursements of Chairs and 

Rapporteurs, special allowance, etc… 

•  EUR 1 081 160,00 were spent for technical assistance (literature search, editing of 

opinions, website mastering and dissemination activities). 

More details can be found in their Activity Report: see activity_report_sc_20132016_en.pdf 
(europa.eu) 

Current budget line: 

For both Committees, as of 2021, the funding comes from the EU budget (EU4Health). In the 
past  it  was  via  Consumer  (DG  JUST)  -  mainly  for  the  SCCS  -  and  via  Health  (SANTE) 
Programmes. 

Future workload and resource needs:  

For chemical work, the future workload and resource needs are estimated under the Cosmetics 
Product  Regulation,  the  Water  Framework  Directive/Environmental  Quality  Standard 

211 

 
 
Directive/Ground water directive, Toys Directive, Medical  Devices Directive, Cross-Border 
Health Threats Regulation and Tobacco Directive for their respective parts.  

For non-chemical work, the experience over the last 10 years shows that the number of opinions 
on non-chemical issues is low and amounts to approximately 1 opinion per year. Majority of 
opinions  on  non-chemical  topics  are  ad-hoc.  There  are  few  examples  of  opinions  that  are 
recurrent, like the once on electromagnetic fields (EMF) and on the use of animals in laboratory 
testing  (one  opinion  approximately  every  5  years).  Currently  the  SAM  delivers  around  3-4 
opinions per year. The additional 1 opinion will therefore represent a significant impact. It is 
estimated that addition 1 FTE for SAM secretariat will be necessary.  

2024: EUR 0  
2025: EUR 0 
2026: EUR 0 
2027: EUR 0 
2028: EUR 0 
2024:  0 TAs, 0 CAs 
2025:  1 TAs, 0 CAs 
2026:  1 TAs, 0 CAs 
2027:  1 TAs, 0 CAs 
2028:  1 TAs, 0 CAs 

Summary of resource needs for non-chemical topics of SCHEER: 

Agency 

Summary of tasks 

SAM Secretariat 

(DG RTD) 

Opinions  on  non-chemical  topics 
of SCHEER 

Financial resource 
needs: 

Human resource 
needs: 

Future budget line: DG RTD 

Candidate for fees: No 

34.  ECODESIGN FOR SUSTAINABLE PRODUCTS REGULATION 

Responsible body: 

Currently: N/A, no current process 

Reattribution planned to: TBC 

Legal basis for reattribution: proposal for Ecodesign for Sustainable Products Regulation. 

Type of task: new 

Brief  task  overview:  The  draft  regulation  sets  a  framework  provisions  and  the  details  of 
implementation (such as scope, IT formats, etc.) will be set at the later stage via the delegated 
or  implementing  acts.  The  framework  provisions  do  not  set  any  direct  obligations  on  the 
Agencies. However, it is expected that as part of the delegated acts Agencies will be required 
to  support  several  technical  tasks  and  operate  IT  systems.  The  topic  of  interest  from  the 
chemical perspective is the digital product passport, where ECHA may be expected to provide 
information on the presence of substances of concern in products (link with the existing SCIP 
database, but expectations would be broader than the current scope of SCIP). ECHA may be 
expected to build a bridge between SCIP and the product passports, but the details of the work 
are not known yet. 

212 

 
 
 
 
 
The draft Regulation also includes a provision for the Commission to request ad-hoc advice 
from the Agencies when assessing the self-regulation measures; it is yet unclear whether and 
which Agencies’ expertise would be required as part of this process and the related workload. 

Proximity to Agencies mandate: ECHA’s core mandate is related to the safety assessment of 
chemicals. The provision of information on the presence of SoC in products could be seen as 
an extension of the mandate from chemicals to products and from risk assessment to providing 
information.  

Main  risks  and  opportunities:  Risk  of  deviating  from  ECHA  core  mandate  of  safety 
assessment  of  chemicals.  The  scope  of  information  on  chemicals  in  the  Digital  Product 
Passports (DPP) is expected not to be the same as in SCIP: Product passport are to report on 
all substances of concern, while SCIP only reports on the presence of Candidate List substances 
(SVHCs), which is at least a 100-fold increase in scope. Currently, with ca. 200 SVHCs in 
scope  ECHA  has  received  already  21  million  SCIP  notifications.  If  the  scope  is  100-fold 
bigger, the number of notifications may become excessive. If the product passport is to be a 
system among the companies, it remains to be seen how ECHA can contribute to such system 
and what role it would play.  

Projected impact on ECHA 

•  ECHA Committees/bodies: no impact. The task does not require involvement of 

ECHA Committees/bodies 

•  ECHA data model and IT infrastructure: high impact. The task requires investment in 

entirely new data structures and IT systems/capabilities 

•  ECHA key experts: high impact. The task heavily relies on expert competencies, 
which are limited within ECHA and also critical to REACH/CLP/BPR regulatory 
tasks 

Projected workload and resource implications  

Current workload and resource use: 

Not yet analysed, as the obligations are not yet clear. This will be done as part of the delegated 
acts once the main act is adopted. 

Future workload and resource needs 

Not yet analysed, as the obligations are not yet clear  

35.  TOBACCO PRODUCTS DIRECTIVE 

Responsible body: 

Currently: Commission with the support of the SCHEER Committee 

Reattribution planned to: TBC 

Legal basis for reattribution: revision of the Tobacco directive (2014/40/EU) 

Type of task: new 

213 

 
 
 
Brief task overview: The tobacco directive is undergoing an evaluation and a revision of the 
directive is  being  envisaged. As part of the revision, a new scientific and technical  work is 
being envisaged that could be potentially attributed to EU Agencies. Currently, Under Article 
6(1), the Commission adopted a decision, establishing a priority list of 15 additives for which 
enhanced  reporting  obligations  are  in  place,  selected  on  the  basis  of  a  SCHEER  scientific 
opinion. It is being considered whether in future in addition, a positive list of ingredients and a 
database would need to be established. In addition, the work may include: 

•  Managing the laboratory network on tobacco control; 
•  Checking compliance with product presentation provisions;  
•  Running the procedure determining characterizing flavour; 
•  Updating negative/positive lists of additives; 
•  Hosting product database and making publicly available the product information;  
•  Monitoring of data in product notifications; 
•  Assessing information on leaflets. 

Proximity  to  Agencies’  mandate:  The  tasks  are  not  yet  clear  but  those  that  are  being 
considered do not naturally fit to the agencies considered in this initiative. 

Main  risks  and  opportunities:  ECHA’s,  EFSA’s  and  EMA’s  core  mandate  relates  to  the 
safety assessment of chemicals to protect human health and the environment. The proposed 
tasks are not related to that core mandate.  

Projected workload and resource implications  

Future workload and resource needs: 

Not yet analysed, as the obligations are not yet clear.  

36.  REGULATION  ON  FLUORINATED  GREENHOUSE  GASES  AND  REGULATION  ON  OZONE 

DEPLETING SUBSTANCES  

Responsible body: 

Currently: Commission and EEA 

Reattribution planned to: TBD 

Legal basis for reattribution: revision of regulation on fluorinated greenhouse gases 
(517/2014) and revision of regulation on ozone depleting substances (1005/2009) 

Type of task: new 

Detailed task overview:  

Current:  

The Commission is implementing a quota and licencing system for hydrofluorocarbons as well 
as  a  similar  system  for  ozone  depleting  substances  (ODS)  that  both  require  registration  of 
importers and producers of these chemicals, determination and allocation of company quota 
and issuing of penalties for non-compliance with the quota system. Annual company reporting 
data is collected and aggregated by the European Environment Agency each year. The agency 

214 

 
 
 
prepares a report on ODS and F-gas related activities for Member State representatives and the 
Commission (DG CLIMA), which includes for instance for F-gases data on imports, exports, 
production, destruction, and reclamation relevant  to  bulk F-gases and equipment  containing 
such gases 

Changes: 

On  5  April  2022,  the  Commission  presented  a  proposal  for  a  regulation  on  fluorinated 
greenhouse gases (F-gases) that would repeal Regulation (EU) No 517/2014 and a proposal 
repealing Regulation on ozone depleting substance (EC) No 1005/2009. The proposal aims to 
further reduce emissions of  these chemicals.  The F-gas  proposal would change the existing 
quota system, gradually reducing the supply of hydrofluorocarbons (HFC) to the EU market to 
approximatively 2.4 % of 2015 levels by 2048 and requiring a quota allocation price which 
needs to be collected. The quota revenue can partly be used for the implementation of the quota 
and licensing system. For ozone depleting substances the quota system will be abolished and 
the  licencing  system  simplified.  Both  licensing  systems  and  labelling  obligations  will  be 
strengthened to improve enforcement of trade and hydrofluorocarbon (HFC) quota restrictions. 
Finally,  the  proposals  would  align  EU  legislation  with  the  requirements  of  the  Montreal 
Protocol.  

The European Environmental Agency (EEA) will have to slightly adapt their reporting tool for 
undertakings  reporting  on  F-gases  and  ozone  depleting  substances,  due  to  changes  in  the 
reporting requirements. 

The  proposal  retains  the  obligation  on  the  Commission  to  set  up  and  operate  an  electronic 
system for the management of the quota system for HFCs as well as the licensing of imports 
and exports and reporting for F-gases and for ozone depleting substances. It is not yet clear 
how the tasks can be implemented most effectively, but it is envisaged that an agency could 
take some of the tasks in case that would be deemed to be the best option at a later stage.  

Proximity to Agencies’ mandate: The Regulations are still under review and tasks related to 
setting-up and operating of the electronic system are not yet fully clear. It thus remains unclear 
if any of the agencies would be suitable for such tasks.  

Projected workload and resource implications  

Future workload and resource needs 

Not yet analysed, as the tasks are not yet defined 

215 

 
 
 
216